Pure Global
Home/Indonesia Database/Authorized Representative
🇮🇩

PT. ABBOTT PRODUCTS INDONESIA

Authorized Representative in Indonesia

Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
941 Products Represented
137 Manufacturers
Total Products
941
Manufacturers
137
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
35 products
3.7%
Kelas Resiko : B
668 products
71.0%
Kelas Resiko : C
187 products
19.9%
Kelas Resiko : D
51 products
5.4%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (941)
Complete portfolio registered with BPOM

ARCHITECT Total T4 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

ALINITY c Lactate Dehydrogenase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

ALINITY c Amylase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

ARCHITECT Consolidated Chemistry Calibrator

Manufacturer:

RANDOX LABORATORIES, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2025

ARCHITECT Total T4 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

MITRACLIP G4 NTW Clip Delivery System

Manufacturer:

ABBOTT MEDICAL (MENLO PARK)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2025

ABBOTT Amylase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2025

MITRACLIP G4 Steerable Guide Catheter

Manufacturer:

ABBOTT MEDICAL. (Menlo park)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 4, 2025

CELL-DYN Emerald 22 Diluent

Manufacturer:

AVANTOR PERFORMANCE MATERIALS S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

ARCHITECT Lactate Dehydrogenase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

ALINITY hs Slide Maker Stainer Module and Accessories

Manufacturer:

SANMINA-SCI SYSTEMS SINGAPORE PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

ALINITY hq Analyzer and Accessories

Manufacturer:

SANMINA-SCI SYSTEMS SINGAPORE PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

SUPERA Peripheral Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 23, 2025

ARCHITECT Ammonia Controls

Manufacturer:

SENTINEL CH., SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2025

ALINITY i Processing Module and Accessories

Manufacturer:

ABBOTT LABORATORIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 6, 2025

MITRACLIP G4 XTW Clip Delivery System

Manufacturer:

ABBOTT MEDICAL (MENLO PARK)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 2, 2025

MITRACLIP G4 NT Clip Delivery System

Manufacturer:

ABBOTT MEDICAL (MENLO PARK)

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 2, 2025

ALINITY i Rubella IgG Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2024

ARCHITECT Syphilis TP Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2024

ALINITY c D-Dimer Controls

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2024

ALINITY c D-Dimer

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 23, 2024

ARCHITECT Rubella IgG Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 23, 2024

CELL-DYN Emerald 22 and Accessories

Manufacturer:

BIT ANALYTICAL INSTRUMENTS GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

ABBOTT Diluent / Sheath (Cell-Dyn Sapphire and Cell-Dyn Ruby Systems

Manufacturer:

ABBOTT LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2024

ALINITY c TDM Multiconstituent Calibrator Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2024

CELL-DYN 22 Plus Calibrator

Manufacturer:

LINE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

ALINITY c Carbamazepine Reagent Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

CELL-DYN 22 Plus Control

Manufacturer:

LINE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

CELL-DYN Emerald 22 Lyse

Manufacturer:

BIT GROUP FRANCE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2024

MINI TREK RX Coronary Dilatation Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 10, 2024

SENTINEL Ammonia Ultra

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

ARMADA 35 LL PTA Catheter

Manufacturer:

ABBOTT VASCULAR COSTA RICA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2024

ARCHITECT HCV Ag Reagent Kit

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 26, 2024

TREK RX Coronary Dilatation Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 26, 2024

VIATRAC 14 Plus Peripheral Dilatation Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2024

ABSOLUTE PRO Peripheral Self-Expanding Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2024

ALINITY i Active-B12 (Holotranscobalamin) Reagent Kit

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2024

ARCHITECT PIVKA-II Calibrators

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2024

ALINITY i Active-B12 (Holotranscobalamin) Controls

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2024

ALINITY c D-Dimer Calibrator

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2024

ARCHITECT Active-B12 (Holotranscobalamin) Controls

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2024

ARMADA 14 PTA Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2024

ALINITY i Active-B12 (Holotranscobalamin) Calibrators

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

ARCHITECT Albumin BCG2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

ARCHITECT Active-B12 (Holotranscobalamin) Calibrators

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

CELL-DYN 29 Plus Control (with retic)

Manufacturer:

LINE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

EMBOSHIELD NAV6 Embolic Protection System

Manufacturer:

ABBOTT VASCULAR, TEMEUCULA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 19, 2024

ALINITY i Anti-HBc IgM Calibrators

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

ARCHITECT CK-MB Control

Manufacturer:

SENTINEL CH., S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2024

ALINITY c Consolidated Chemistry Calibrator

Manufacturer:

RANDOX LABORATORIES, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2024

ALINITY i PIVKA-II Reagent Kit

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2024

TECHNOPATH Multichem hsTn

Manufacturer:

TECHNO-PATH MANUFACTURING LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2024

ABSOLUTE PRO LL Peripheral Self-Expanding Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2024

FREESTYLE Optium Neo H Blood Glucose and Ketone Monitoring System

Manufacturer:

FLEXTRONICS MEDICAL DEVICE MANUFACTURING (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2024

ARCHITECT Bilirubin Calibrator

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

FREESTYLE Optium Neo H Blood Glucose Test Strips

Manufacturer:

ABBOTT DIABETES CARE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 9, 2024

ALINITY c CRP Vario HS Control Kit

Manufacturer:

SENTINEL CH. S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

ARCHITECT Cyclosporine Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

ARCHITECT CRP Control HS

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

X.ACT Carotid Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 6, 2024

FREESTYLE Optium H Blood β Ketone Test Strips

Manufacturer:

ABBOTT DIABETES CARE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

ALINITY i Anti-HBc IgM Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

ALINITY i Cyclosporine Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

ARCHITECT CK-MB Calibrator

Manufacturer:

SENTINEL CH., S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

ALINITY i Anti-HBc IgM Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 30, 2024

ALINITY i Cyclosporine Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 30, 2024

ARCHITECT Cyclosporine Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2024

ARCHITECT 25-OH Vitamin D Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

FREESTYLE Optium Neo Blood Glucose and Ketone Monitoring System

Manufacturer:

FLEXTRONICS MEDICAL DEVICE MANUFACTURING (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2024

ARCHITECT Calcium2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

ARCHITECT 25-OH Vitamin D Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

ALINITY c Phosphorus Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2024

ALINITY c-series Acid Wash

Manufacturer:

FISHER DIAGNOSTICS A DIV. OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 14, 2024

ALINITY c Lithium Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

ARCHITECT SCC Controls

Manufacturer:

DENKA SEIKEN CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

ARCHITECT HAVAb-IgM Reagent Kit

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

ALINITY h-series AutoClean Solution

Manufacturer:

AUG. HEDINGER GMBH & CO. KG.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 9, 2024

ARCHITECT Free T4 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2024

HI-TORQUE Command Guide Wire

Manufacturer:

ABBOTT VASCULAR.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

ARCHITECT BNP Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

ARCHITECT 25-OH Vitamin D Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

ALINITY i CA 19-9XR Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

ALINITY i BNP Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

ALINITY i CA 19-9XR Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

ALINITY i CA 19-9XR Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

ARCHITECT CA 19-9XR Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 1, 2024

ARCHITECT CA 125 II Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 27, 2024

ARCHITECT CA 125 II Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 24, 2024

ARCHITECT CA 19-9 XR Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 24, 2024

ARCHITECT CA 125 II Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

ARCHITECT CA 19-9 XR Calibrators

Manufacturer:

Fujirebio Diagnostics, Inc.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

FREESTYLE Optium Blood Glucose Test Strips

Manufacturer:

ABBOTT DIABETES CARE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 5, 2024

ABBOTT Folate Lysis Reagent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2024

ALINITY i Folate Lysis Reagent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2024

ARCHITECT STAT High Sensitive Troponin-I Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

ALINITY i STAT High Sensitive Troponin-I Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

ALINITY i STAT High Sensitive Troponin-I Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

ALINITY i Folate RBC Lysis Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

ALINITY c-series ICT Reference Solution

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2024

ALINITY c Urine/CSF Protein Calibrator Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

ARCHITECT Free PSA Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

MEDISENSE Glucose & Ketone Control Solutions

Manufacturer:

BIONOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

ALINITY Trigger Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 14, 2024

ARCHITECT Folate RBC Lysis Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

ARCHITECT Free PSA Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 8, 2024

ARCHITECT Pre-Trigger Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 8, 2024

ALINITY h-series Hemcal

Manufacturer:

LINE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

ALINITY i HBeAg Quantitative Calibrators

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

Alinity c Alanine Aminotransferase Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

ALINITY c ICT Serum Calibrator Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

ALINITY c ASO Reagent Kit

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 8, 2024

ALINITY Pre-Trigger Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 8, 2024

ALINITY c Creatine Kinase Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

HI-TORQUE Command ES Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

HI-TORQUE Command 18 ST Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

ARCHITECT Trigger Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2024

ALINITY i CA 125 II Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

ALINITY i HE4 Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

ALINITY i CA 125 II Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

ALINITY i HE4 Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

ALINITY i HE4 Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

ALINITY i CA 125 II Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

ARCHITECT Rubella IgG Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

FREESTYLE Optium Blood β-Ketone Test Strips

Manufacturer:

ABBOTT DIABETES CARE LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2024

ARCHITECT Rubella IgG Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 30, 2024

ALINITY c Urine / CSF Protein Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2024

ALINITY c Digitoxin Reagent Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

ALINITY c Digitoxin Standard

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

ALINITY i Syphilis TP Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

ALINITY h-series Control 29P

Manufacturer:

LINE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

ALINITY c Digitoxin Controls

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2024

ALINITY i HBeAg Quantitative Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2024

ALINITY c Multiconstituent Calibrator Kit

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 24, 2024

ALINITY i Syphilis TP Controls

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

ARCHITECT Tacrolimus Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

ARCHITECT Tacrolimus Whole Blood Precipitation Reagent

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

ARCHITECT Syphilis TP Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

ARCHITECT Syphilis TP Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

ALINITY c Ultra HDL Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 8, 2024

ALINITY c Bilirubin Calibrator Kit

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

ALINITY c Calcium Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

ALINITY c ICT Urine Calibrator Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

ARCHITECT Anti-HCV Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 4, 2024

ALINITY c Carbon Dioxide Calibrator Kit

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 4, 2024

ALINITY i Syphilis TP Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2024

ALINITY c Direct Bilirubin Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

ALINITY c Hemoglobin A1c Controls

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

ALINITY c Hemoglobin A1c Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

ALINITY c Hemoglobin A1c Calibrators

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

ARCHITECT Anti-HCV Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

ARCHITECT Anti-HCV Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2024

ALINITY i HAVAb IgG Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

ARCHITECT Anti-Tg Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2024

ALINITY i Anti-HBc II Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2024

ALINITY i Anti-HBc II Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2024

ALINITY i Anti-HBc II Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 10, 2024

ALINITY i HIV Ag/Ab Combo Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 10, 2024

ALINITY i HAVAb IgG Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

ALINITY i HAVAb IgG Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

ALINITY c ICT Sample Diluent

Manufacturer:

FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

ALINITY c Lactic Acid Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

ALINITY i Prolactin Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

ARCHITECT Anti-Tg Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

ALINITY c Urea Nitrogen Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

ALINITY i HIV Ag/Ab Combo Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

ALINITY i HIV Ag/Ab Combo Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

ALINITY i SCC Controls

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2024

ALINITY i SCC Reagent Kit

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2024

ARCHITECT Anti-TPO Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2024

ABBOTT Microalbumin

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2024

ALINITY i Prolactin Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

ARCHITECT SCC Reagent Kit

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2024

ALINITY i Toxo IgM Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2024

ALINITY i BNP Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 27, 2024

ARCHITECT Anti-Tg Controls

Manufacturer:

FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

ARCHITECT BNP Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

ALINITY i Toxo IgG Avidity Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

ALINITY i Tacrolimus Whole Blood Precipitation Reagent

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2024

ARCHITECT Prolactin Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

ARCHITECT Prolactin Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

ALINITY i Tacrolimus Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2024

ARCHITECT Cortisol Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

ALINITY i SCC Calibrators

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

ARCHITECT Anti-HBc IgM Reagent Kit

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 13, 2024

ALINITY and Toxo IgM Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2024

ALINITY i HBeAg Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

ARCHITECT Galectin-3 Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

ARCHITECT Galectin-3 Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

ALINITY i Toxo IgG Avidity Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2024

ALINITY i Toxo IgM Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2024

ARCHITECT Galectin-3 Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

ARCHITECT Cortisol Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY,LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

ARCHITECT HBeAg Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 6, 2024

ARCHITECT Anti-HBc IgM Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

ALINITY i STAT CK-MB Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

ALINITY i Anti-HBe Calibrator

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2024

ALINITY and Toxo IgG Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 25, 2024

ALINITY i HBeAg Calibrators

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

ALINITY i Anti-HBe Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2024

ARCHITECT HBeAg Quantitative Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2024

ARCHITECT HAVAb-IgG Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2024

ALINITY i Progesterone Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

ARCHITECT Progesterone Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

ARCHITECT Progesterone Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

ALINITY i Progesterone Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

ARCHITECT HIV Ag/Ab Combo Reagent Kit

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

ARCHITECT Anti-HBc IgM Calibrators

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

ARCHITECT HIV Ag/Ab Combo Controls

Manufacturer:

ABBOTT GMBH,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

ALINITY i Anti-TPO Controls

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

ALINITY i Toxo IgG Calibrators

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2024

ARCHITECT HBeAg Quantitative Calibrators

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2024

ALINITY i Toxo IgG Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 3, 2024

ARCHITECT STAT CK-MB Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2024

ALINITY i Anti TPO Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2024

ALINITY i B.R.A.H.M.S PCT Controls

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2024

ALINITY i B.R.A.H.M.S PCT Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

ALINITY i HAVAb IgM Reagent Kit

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2024

ALINITY i CA 15-3 Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 8, 2024

ARCHITECT Homocysteine Controls

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2024

ARCHITECT HBsAg Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 6, 2024

ALINITY i CA 15-3 Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 5, 2024

ARCHITECT STAT CK-MB Controls

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

ALINITY i Progesterone Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

ARCHITECT CA 15-3 Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 5, 2024

ARCHITECT CA 15-3 Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 5, 2024

ARCHITECT CA 15-3 Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 5, 2024

Alinity i HAVAb IgM Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

ALINITY i CA 15-3 Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 5, 2024

FREESTYLE Lancets

Manufacturer:

FACET TECHNOLOGIES, LLC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 5, 2024

ARCHITECT STAT Myoglobin Controls

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 4, 2024

ARCHITECT HIV Ag/Ab Combo Calibrator

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

ARCHITECT Homocysteine Calibrators

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

ARCHITECT HBsAg Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

ALINITY i 2nd Generation Testosterone Controls

Manufacturer:

Axis-Shield Diagnostics Limited

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

ALINITY i 2nd Generation Testosterone Calibrators

Manufacturer:

Axis-Shield Diagnostics Limited

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

Alinity i 2nd Generation Testosterone Reagent Kit

Manufacturer:

Axis-Shield Diagnostics Limited

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

ARCHITECT 2nd Generation Testosterone Reagent Kit

Manufacturer:

Axis-Shield Diagnostics Limited

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2024

Alinity i HAVAb IgM Calibrator

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2024

ARCHITECT STAT Myoglobin Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIV . OF FISHER SCIENTIFIC COMPANY,LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2024

ARCHITECT HBsAg Qualitative II Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2024

ARCHITECT STAT Myoglobin Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIV . OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2024

ARCHITECT HBsAg Qualitative II Confirmatory Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

ARCHITECT HBsAg Qualitative II Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISON.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

ARCHITECT 2nd Generation Testosterone Controls

Manufacturer:

Axis-Shield Diagnostics Limited

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

ARCHITECT 2nd Generation Testosterone Calibrators

Manufacturer:

Axis-Shield Diagnostics Limited

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2024

Quantia β2-Microglobulin

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

ALINITY c Glucose Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 13, 2024

Quantia β2-Microglobulin Standard

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2024

ABBOTT Specific Proteins Multiconstituent Calibrator

Manufacturer:

NITTOBO MEDICAL CO. LTD., MEDICAL DEVELOPMENT CENTER

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2024

Quantia PROTEINS Control

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 4, 2024

ABBOTT Total Bilirubin

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

ABBOTT Prealbumin Calibrator

Manufacturer:

NITTOBO MEDICAL CO., LTD MEDICAL DEVELOPMENT CENTER

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

Quantia Ferritin Standard

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

ALINITY i GFAP Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 27, 2024

ALINITY i Folate Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

ALINITY i UCH-L1 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

ARCHITECT Folate Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

ARCHITECT Folate Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2023

ALINITY i Folate Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2023

HI-TORQUE Winn Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 13, 2023

ALINITY c Iron Calibrator Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2023

ALINITY c Processing Module and Accessories

Manufacturer:

CANON MEDICAL SYSTEMS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2023

ARCHITECT i1000SR Integrated Module

Manufacturer:

ABBOTT LABORATORIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

HI-TORQUE PILOT Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2023

SENTINEL Lipase NG OC Cal

Manufacturer:

SENTINEL CH. SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2023

SENTINEL Lipase NG OC CTRL 1

Manufacturer:

SENTINEL CH. SPA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

NSE Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 27, 2023

SENTINEL Lipase NG OC Reagent Kit

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

NSE Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 27, 2023

NSE Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 27, 2023

SENTINEL Lipase NG OC CTRL 2

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 27, 2023

CELL-DYN HemCal Plus Calibrator

Manufacturer:

STRECK LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

ALINITY i Galectin-3 Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

Alinity i Galectin-3 Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

ALINITY i Galectin-3 Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

ARCHITECT Pepsinogen I Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

CELL-DYN Enzymatic Cleaner Concentrate

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 8, 2023

HI-TORQUE Winn 80 Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

ALINITY i STAT CK-MB Controls

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

ARCHITECT Pepsinogen II Calibrators

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ARCHITECT Pepsinogen I Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ARCHITECT Pepsinogen II Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ARCHITECT Sirolimus Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ARCHITECT Pepsinogen I Calibrator

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

HI-TORQUE Pilot 150 Guide Wire with Hydrophilic Coating

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 26, 2023

ALINITY i STAT CK-MB Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2023

GRAFTMASTER RX Coronary Stent Graft System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 25, 2023

ALINITY i Sirolimus Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

ALINITY i STAT Myoglobin Controls

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2023

CELL-DYN Ruby and Accessories

Manufacturer:

FLEXTRONICS MANUFACTURING (SINGAPORE) PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 23, 2023

RX Herculink Elite Peripheral Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2023

ARCHITECT Pepsinogen II Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2023

QUANTIA RF Standard

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

ALINITY i STAT Myoglobin Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2023

ASO Standard AMOUNT

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2023

Standard IgE Amount

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2023

ALINITY c Ferritin/Myoglobin/IgE Control Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2023

NC TREK NEO™ Coronary Dilation Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2023

ABBOTT Alinity m EBV AMP Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2023

ABBOTT Alinity m EBV CTRL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2023

ARCHITECT HBsAg Next Qualitative Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

ARCHITECT i1000 SR Processing Module and Accessories

Manufacturer:

ABBOTT LABORATORIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

ABBOTT Lp(a) Control

Manufacturer:

BIOKIT S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2023

RF AMOUNT

Manufacturer:

BIOKIT S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 22, 2023

ARCHITECT Anti-TPO Controls

Manufacturer:

FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2023

ASO AMOUNT

Manufacturer:

BIOKIT S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

ARCHITECT Cortisol Calibrators

Manufacturer:

FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

QUANTIA D-Dimer Standard

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

Amount D-Dimer Control

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2023

ARCHITECT Homocysteine Reagent Kit

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2023

Alinity h-series May-Grünwald-Giemsa Stain

Manufacturer:

AVANTOR PERFORMANCE MATERIALS POLAND S.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 14, 2023

AMOUNT D-Dimer

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2023

ALINITY h-series Wright-Giemsa Stain

Manufacturer:

AVANTOR PERFORMANCE MATERIALS POLAND S.A

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 14, 2023

AMOUNT Ferritin

Manufacturer:

BIOKIT S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2023

AMOUNT IgE

Manufacturer:

BIOKIT S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2023

ALINITY c ASO-RF Control I Kit

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2023

TECHNOPATH Multichem WBT

Manufacturer:

TECHNO-PATH MANUFACTURING, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

ALINITY c Myoglobin Standard

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

ALINITY c Myoglobin Reagent Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2023

ALINITY c ASO-RF Control II Kit

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

Quantia Ferritin/Myoglobin/IgE Control

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

AMOUNT ASO-RF Control I

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

Lp(a) Calibrators

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2023

Alinity c RF Reagent Kit

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2023

ALINITY c ASO Standard

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2023

AMOUNT Lp(a)

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2023

ALINITY c Lp(a) Reagent Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

ALINITY c RF Standard

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 17, 2023

ALINITY c Lp(a) Calibrators

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

Xience Xpedition Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 15, 2023

PERCLOSE PROGLIDE Suture-Mediated Closure System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 15, 2023

ARCHITECT SHBG Reagent Kit

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

ALINITY c Lp(a) Control Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

ARCHITECT DHEA-S Controls

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

ARCHITECT DHEA-S Reagent Kit

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

ARCHITECT SCC Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

ARCHITECT DHEA-S Calibrators

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

ARCHITECT SHBG Calibrators

Manufacturer:

BIOKIT S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2023

ARCHITECT SHBG Controls

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2023

ABBOTT Alinity m SARS-CoV-2 AMP Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2023

TECHNOPATH Multichem P

Manufacturer:

TECHNO-PATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

TECHNOPATH Multichem WBT

Manufacturer:

TECHNOPATH MANUFACTURING, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

XIENCE Sierra Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 25, 2023

TECHNOPATH Multichem A1c

Manufacturer:

TECHNO-PATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

XIENCE ProA Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 15, 2023

ARCHITECT ARM Concentrated Wash Buffer

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 14, 2023

ARCHITECT iGentamicin Calibrators

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

Lipase Calibrator

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ARCHITECT Methotrexate Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ARCHITECT Methotrexate Extended Range Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

ARCHITECT iGentamicin Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

ARCHITECT Methotrexate Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 4, 2023

ARCHITECT Direct LDL

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

ARCHITECT Methotrexate Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2023

ARCHITECT Thyroglobulin Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2023

Abbott Gamma-Glutamyl Transferase

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 25, 2023

ARCHITECT Thyroglobulin Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

ARCHITECT Thyroglobulin Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2023

ARCHITECT TSH Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2023

ARCHITECT TSH Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2023

ARCHITECT HE4 Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2023

ARCHITECT HE4 Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 16, 2023

CELL-DYN Emerald 22 AL and accessories

Manufacturer:

BIT ANALYTICAL INSTRUMENTS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

ARCHITECT T-Uptake Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

Multiconstituent Calibrator

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

ALINITY c Lipid Multiconstituent Calibrator Kit

Manufacturer:

RANDOX LABORATORIES, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

ARCHITECT T-Uptake Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

ARCHITECT Total β -hCG Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2023

ARCHITECT STAT High Sensitive Troponin-I Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2023

ALINITY i Intact PTH Reagent Kit

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2023

ALINITY i Intact PTH Controls

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2023

ALINITY i Intact PTH Calibrators

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2023

ARCHITECT T-Uptake Controls

Manufacturer:

FISHER DIAGNOSTICS,A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2023

ARCHITECT C-Peptide Controls

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 5, 2023

ARCHITECT C-Peptide Reagent Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

ALINITY c Ethanol Control Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

ARCHITECT Progesterone Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 28, 2023

ARCHITECT i Theophylline Reagent Kit

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

ALINITY c Ethanol Reagent Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

ARCHITECT i Theophylline Calibrators

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

ARCHITECT C-Peptide Calibrators

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

ARCHITECT Trigger Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 22, 2023

ALINITY c Valproic Acid Reagent Kit

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ABBOTT Carbon Dioxide Calibrator

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ARCHITECT Intact PTH Calibrators

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ALINITY c Ethanol Calibrator Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ARCHITECT HBsAg Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ALINITY i Insulin Controls

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

Triclip G4 System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 19, 2023

ARCHITECT Intact PTH Reagent Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

ARCHITECT Urine NGAL Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

ALINITY C Theophylline Reagent Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

ARCHITECT Intact PTH Controls

Manufacturer:

BIOKIT, S.A.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

ALINITY i Insulin Reagent Kit

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2023

ARCHITECT CMV IgM Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTIC DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 16, 2023

ARCHITECT Concentrated Wash Buffer

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 16, 2023

ALINITY c Phenobarbital Reagent Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2023

ABBOTT Creatine Kinase

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2023

ABBOTT Glucose

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2023

ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 4, 2023

ABBOTT Direct Bilirubin

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 4, 2023

ARCHITECT STAT CK-MB Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2023

ABBOTT TDM Multiconstituent Calibrator

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2023

ARCHITECT Free T4 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ARCHITECT Total T3 Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ARCHITECT Insulin Calibrators

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ARCHITECT CMV IgM Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

ARCHITECT Rubella IgM Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

ARCHITECT CMV IgG Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

ARCHITECT Prolactin Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ARCHITECT Free T4 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ARCHITECT Insulin Reagent Kit

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 10, 2023

ABBOTT Lactic Acid

Manufacturer:

FISHER DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2023

ALINITY i Anti-Tg Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2023

ALINITY i Anti-Tg Controls

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2023

ARCHITECT CMV IgG Avidity Reagent kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 5, 2023

ARCHITECT CMV IgG Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 5, 2023

ARCHITECT CMV IgG Avidity Calibrator & Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 5, 2023

ALINITY i ProGRP Calibrators

Manufacturer:

DENKA CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 3, 2023

ALINITY i Anti-Tg Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2023

ARCHITECT rHTLV-I/II Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2023

ABBOTT Aspartate Aminotransferase

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2023

ALINITY i UCH-L1 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2023

ABBOTT Triglyceride

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2023

ABBOTT ICT Urine Calibrator

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2023

ARCHITECT rHTLV-I/II Reagent

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 28, 2023

ABBOTT Ultra HDL

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2023

ABBOTT Urine/CSF Protein

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2023

GFAP Calibrators For Use With Alinity i

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2023

ABBOTT Phosphorus

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2023

GFAP Reagent Kit For Use With Alinity i

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

UCH-L1 Reagent Kit For Use With Alinity i

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

ARCHITECT CMV IgM Calibrator

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

ABBOTT Alanine Aminotransferase For Use With Architect

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

ABBOTT Carbon Dioxide For Use With Architect

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

ARCHITECT CMV IgG Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

ARCHITECT HBsAg Qualitative II Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2023

ARCHITECT Rubella IgM Calibrator

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2023

ARCHITECT Rubella IgM Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2023

ALINITY c Direct LDL Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2023

ARCHITECT Lactic Acid2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 3, 2023

ALINITY c Lactic Acid2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2023

ARCHITECT Calcium

Manufacturer:

Fisher Diagnostics, A Div. Of Fisher Scientific Company, LLC A Part Of Thermo Fisher Scientific, Inc.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2023

ARCHITECT rHTLV-I/II Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 20, 2023

ARCHITECT STAT Myoglobin Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2023

ALINITY i-series Probe Conditioning Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 15, 2023

ALINITY i Pepsinogen I Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2023

ARCHITECT i Carbamazepine Calibrators

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2023

ARCHITECT i Carbamazepine Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2023

ARCHITECT LH Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2023

Alinity h-series WBC Reagent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

ARCHITECT Total β-hCG Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

ARCHITECT LH Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

ARCHITECT Ferritin Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

ARCHITECT STAT Myoglobin Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

ABBOTT Lactate Dehydrogenase

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

ABBOTT ICT Serum Calibrator

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

ARCHITECT TSH Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

ARCHITECT Ferritin Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

ARCHITECT Anti-Tg Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ARCHITECT Ferritin Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ARCHITECT Folate Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ARCHITECT Cortisol Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ARCHITECT STAT Myoglobin Controls

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ARCHITECT STAT CK-MB Controls

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

Alinity c-series Maintenance Solution

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 24, 2023

TECHNOPATH Multichem U

Manufacturer:

TECHNOPATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

ALINITY i Pepsinogen II Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

TECHNOPATH Multichem IA Plus

Manufacturer:

TECHNOPATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

ARCHITECT CEA Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2022

TECHNOPATH Multichem S Plus (Unassayed)

Manufacturer:

TECHNOPATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2022

ARCHITECT CEA Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

ARCHITECT Free PSA Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

ARCHITECT Total PSA Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

ARCHITECT CEA Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

TECHNOPATH Multichem S Plus (Assayed)

Manufacturer:

TECHNOPATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

ARCHITECT Total PSA Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

ARCHITECT Total PSA Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

ALINITY i Methotrexate Extended Range Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2022

ALINITY i Pepsinogen I Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2022

ALINITY i Pepsinogen II Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

ALINITY i Pepsinogen I Calibrators

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

HI-TORQUE PILOT 50 Guide Wire With Hydrophylic Coating

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2022

ALINITY i Pepsinogen II Calibrators

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

CELL-DYN Retic Plus Control

Manufacturer:

LINE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

HI-TORQUE VERSATURN Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 6, 2022

Alinity c Total Bile Acids Calibrator Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

ALINITY i CYFRA 21-1 Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2022

ALINITY c CK-MB Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2022

ALINITY c CRP Vario Wide Range Calibrator Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2022

ARCHITECT Ceruloplasmin

Manufacturer:

SENTINEL CH, SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2022

ALINITY c UIBC Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

ALINITY c UIBC Calibrator Kit

Manufacturer:

SENTINEL CH. S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

ALINITY c CK-MB Calibrator Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

ALINITY c CK-MB Control Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

ALINITY c Iron Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

ALINITY c Immuno Control 2 Kit

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2022

ARCHITECT i2000 SR and Accessories

Manufacturer:

FLEXTRONICS MANUFACTURING (SINGAPORE) PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2022

ALINITY c Cholinesterase Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 17, 2022

ALINITY c Clinical Chemistry Calibrator Kit

Manufacturer:

SENTINEL CH., SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

ALINITY c Plasmaproteins Cal 3x Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

ALINITY c Ceruloplasmin Reagent Kit

Manufacturer:

SENTINEL CH S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

ALINITY c Clinical Chemistry Control 2 Kit

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2022

ARCHITECT Cystatin C Calibrator

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2022

ALINITY c Creatinine (Enzymatic) Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2022

ABBOTT Immuno Control 2

Manufacturer:

SENTINEL CH, SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2022

ARCHITECT Immuno Control Set

Manufacturer:

SENTINEL CH, SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

ALINITY c CRP Vario High Sensitivity Calibrator Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

ALINITY c CRP Vario Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

ARCHITECT Anti-Tg Controls

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

ALINITY c Clinical Chemistry Control 1 Kit

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

ALINITY c Immuno Control Set

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

Abbott Alinity m HIV-1 AMP Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 9, 2022

ABBOTT Clin Chem Cal

Manufacturer:

SENTINEL CH SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

ALINITY c Immuno Control 1 Kit

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

ARCHITECT Immuno Control 1

Manufacturer:

SENTINEL CH, SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

ABBOTT Plasmaproteins Cal 3x

Manufacturer:

SENTINEL CH, SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

ARCHITECT c8000 Processing Module and Accessories

Manufacturer:

CANON MEDICAL SYSTEMS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

ALINITY i ProGRP Reagent Kit

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 7, 2022

ALINITY i SCC Reagent Kit

Manufacturer:

DENKA SEIKEN CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

ABBOTT CRP Calibrator HS

Manufacturer:

SENTINEL CH, SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2022

ARCHITECT Anti-TPO Calibrators

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2022

ABBOTT Cystatin C

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2022

ALINITY i SHBG Controls

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2022

ALINITY i SHBG Calibrators

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2022

ALINITY i PIVKA-II Reagent Kit

Manufacturer:

DENKA SEIKEN CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2022

ALINITY i B.R.A.H.M.S PCT Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

ALINITY i C-Peptide Reagent Kit

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

ALINITY i SHBG Reagent Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

ALINITY i DHEA-S Reagent Kit

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

ALINITY i Homocysteine Calibrators

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

HI-TORQUE Proceed 170T Angled Guide Wire with Hydrophilic Coating

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 26, 2022

HI-TORQUE Proceed 220T Angled Guide Wire with Hydrophilic Coating

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 26, 2022

ALINITY i C-Peptide Controls

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

ALINITY i Homocysteine Reagent Kit

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

ALINITY i C-Peptide Calibrators

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

AlinIQ AMS

Manufacturer:

ABBOTT S.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 24, 2022

ALINITY i ProGRP Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

ALINITY c Prealbumin Calibrator Kit

Manufacturer:

NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

ARCHITECT Anti-TPO Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2022

ARCHITECT Total β-hCG Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2022

ALINITY i ProGRP Controls

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2022

ARCHITECT Toxo IgG Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2022

ALINITY i Homocysteine Controls

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2022

ALINITY i Anti-CCP Controls

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2022

ALINITY i Anti-CCP Calibrators

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2022

ALINITY i Anti-CCP Reagent Kit

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2022

ARCHITECT STAT CK-MB Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2022

Alinity i NSE Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2022

ALINITY c Pancreatic Amylase Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2022

ABBOTT CRP Vario

Manufacturer:

SENTINEL CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2022

SENTINEL Cystatin C Control Set

Manufacturer:

SENTINEL CH SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2022

ABBOTT Alinity m SARS-CoV-2 CTRL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

ABBOTT Creatinine (Enzymatic)

Manufacturer:

SENTINEL CH. S.PA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

ALINITY i Folate Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

CELL-DYN Emerald Diluent

Manufacturer:

CLINICAL DIAGNOSTIC SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

ARCHITECT Rubella IgM Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 26, 2022

CELL-DYN Emerald CN-Free Lyse

Manufacturer:

CLINICAL DIAGNOSTIC SOLUTIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2022

ARCHITECT iPhenytoin Reagent kit

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

ARCHITECT Cyfra 21-1 Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2022

ALINITY i Rubella IgM Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2022

ARCHITECT Cyfra 21-1 Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 8, 2022

ARCHITECT Cyfra 21-1 Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 8, 2022

ARCHITECT Toxo IgG Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2022

CELL-DYN Sapphire System WBC Reagent-Part A

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2022

HI-TORQUE WHISPER Guide Wire

Manufacturer:

ABBOTT VASCULAR.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2022

CELL-DYN Diluent/Sheath (CELL-DYN Sapphire and CELL-DYN Ruby Systems)

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 1, 2022

ARCHITECT Toxo IgG Avidity Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 1, 2022

ARCHITECT Toxo IgG Calibrators

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2022

ARCHITECT iPhenytoin Calibrators

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ARCHITECT iValproic Acid Reagent Kit

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ARCHITECT iValproic Acid Calibrators

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ARCHITECT HE4 Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 29, 2022

CELL-DYN Sapphire System WBC Reagent-Part B

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

ALINITY i Progesterone Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 29, 2022

CELL-DYN Emerald 22 Lyse

Manufacturer:

BIT GROUP FRANCE

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

ABBOTT Alinity m HIV-1 CAL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2022

ARCHITECT Toxo IgG Avidity Calibrator & Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2022

CELL-DYN Ruby Systems WBC Lyse

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ALINITY i LH Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

CELL-DYN Ruby Systems CN-Free HGB/NOC Lyse

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

CELL-DYN Sapphire Systems CN-FREE HGB Reagent

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ALINITY i LH Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ARCHITECT Iron2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2022

ALINITY c Alkaline Phosphatase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2022

ALINITY c Iron2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2022

ARCHITECT iPhenobarbital Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2022

ARCHITECT B12 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2022

ABBOTT Alinity m HR HPV CTRL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2022

ARCHITECT Hemoglobin A1c Calibrators

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 18, 2022

ALINITY i FSH Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

ABBOTT ALINITY m HBV CTRL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

ALINITY c Creatinine2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2022

ARCHITECT Aspartate Aminotransferase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2022

ALINITY i TRAb Calibrators

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ARCHITECT Alkaline Phosphatase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ABBOTT ALINITY m HCV CTRL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

Abbott Alinity m HBV CAL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

Abbott Alinity m HCV CAL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ALINITY i TRAb Controls

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ARCHITECT Anti-CCP Reagent Kit

Manufacturer:

AXIS SHIELD DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2022

CELL-DYN Emerald Cleaner

Manufacturer:

CLINICAL DIAGNOSTIC SOLUTIONS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 12, 2022

ALINITY h-series Diluent

Manufacturer:

FISHER DIAGNOSTICS A DIV . OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ALINITY c Total Bilirubin2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ALINITY i TRAb Reagent Kit

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ARCHITECT Total Bilirubin2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ARCHITECT Anti CCP Calibrators

Manufacturer:

AXIS SHIELD DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 9, 2022

ARCHITECT Anti CCP Controls

Manufacturer:

AXIS SHIELD DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 9, 2022

ARCHITECT Hemoglobin A1c

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2022

ALINITY c Alanine Aminotransferase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2022

ALINITY c Total Bilirubin Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

ALINITY c Aspartate Aminotransferase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

ARCHITECT Hemoglobin A1c Controls

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

ALINITY i FSH Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

ALINITY i FSH Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2022

ARCHITECT HCV Ag Controls

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2022

ALINITY m multi-Collect Specimen Collection Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 18, 2022

ARCHITECT Gamma-Glutamyl Transferase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2022

Abbott Alinity m Lysis solution

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

ARCHITECT Anti-HBC II Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

Abbott Alinity m Diluent Solution

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

ABBOTT Alinity m Sample Prep Kit 1

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

ARCHITECT Anti-HBC II Calibrator

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2022

ALINITY c Digoxin Reagent Kit

Manufacturer:

MICROGENICS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2022

ALINITY c Phenytoin Reagent Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2022

ALINITY c Gentamicin Reagent Kit

Manufacturer:

MICROGENICS CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2022

ARCHITECT Anti-HBc II Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2022

ARCHITECT HCV Ag Calibrators

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2022

ARCHITECT Toxo IgM Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 1, 2022

ARCHITECT Toxo IgM Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 1, 2022

ARCHITECT HSV-2 IgG Reagent Kit

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 1, 2022

ARCHITECT HSV-1 IgG Controls

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 28, 2022

ARCHITECT Toxo IgM Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 22, 2022

TECHNOPATH Multichem IA Plus

Manufacturer:

TECHNOPATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2022

TECHNOPATH Multichem S Plus (Assayed)

Manufacturer:

TECHNOPATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

TECHNOPATH Multichem S Plus (Unassayed)

Manufacturer:

TECHNOPATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

TECHNOPATH Multichem U

Manufacturer:

TECHNOPATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

TECHNOPATH Multichem P

Manufacturer:

TECHNOPATH MANUFACTURING LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

ALINITY hq Analyzer and Accessories

Manufacturer:

SANMINA-SCI SYSTEMS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2022

ARCHITECT Cholinesterase

Manufacturer:

SENTINEL CH., SPA.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 4, 2022

ALINITY i Cortisol Calibrators

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2022

ABBOTT Alanine Aminotransferase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2022

ALINITY h-series HGB Reagent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2022

ALINITY i Total PSA Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2022

ALINITY i Total PSA Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 24, 2022

ALINITY i Total PSA Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2022

ALINITY i Free PSA Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 16, 2022

ALINITY i Free PSA Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 16, 2022

ALINITY i Free PSA Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 14, 2022

ARCHITECT Anti-HCV Controls

Manufacturer:

Abbott GmbH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2022

ARCHITECT Anti-HCV Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 9, 2022

ABBOTT Triglyceride2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2022

ALINITY c Triglyceride2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 11, 2022

ABBOTT UIBC

Manufacturer:

SENTINEL CH, S.P.A..

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2022

ARCHITECT Total T3 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2022

ARCHITECT CRP Calibrator Set

Manufacturer:

SENTINEL CH., SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2022

ARCHITECT CK-MB

Manufacturer:

SENTINEL CH SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2022

ARCHITECT Free T3 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2022

ARCHITECT Free T3 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 28, 2022

ARCHITECT Clin Chem Control 1

Manufacturer:

Sentinel CH. SpA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2022

ARCHITECT Clin Chem Control 2

Manufacturer:

SENTINEL CH., SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2022

ALINITY i T-Uptake Controls

Manufacturer:

FISHER DIAGNOSTICS IS PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2022

CELL-DYN Emerald Diluent

Manufacturer:

CLINICAL DIAGNOSTIC SOLUTION INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2021

ALINITY c Microalbumin Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

ALINITY i Anti-HBs Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 15, 2021

ARCHITECT Anti-HBe Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2021

ARCHITECT Anti-HBe Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 9, 2021

ALINITY c Ammonia Ultra Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2021

ARCHITECT Anti-HBs Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 7, 2021

CELL DYN Sapphire and Accessories

Manufacturer:

FLEXTRONICS MANUFACTURING PTE. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2021

ALINITY i HBsAg Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2021

ALINITY i HBsAg Quantitative Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 27, 2021

ALINITY i CMV IgG Avidity Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2021

ABBOTT CN-Free HGB/NOC Lyse (Cell-Dyn Ruby, Cell DYn 3200 System)

Manufacturer:

ABBOTT LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2021

ARCHITECT Anti-HBe Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2021

CELL-DYN Emerald CN-Free Lyse

Manufacturer:

ABBOTT LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2021

ARCHITECT HBeAg Calibrators

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2021

ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2021

ALINITY c Ammonia Controls

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2021

CELL-DYN Emerald Cleaner

Manufacturer:

ABBOTT LABORATORIES.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 20, 2021

CELL-DYN Reticulocyte Reagent

Manufacturer:

ABBOTT LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2021

ALINITY c Albumin BCP Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

ALINITY c Microalbumin Controls

Manufacturer:

FISHER DIAGNOSTICS IS PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

ARCHITECT Anti-HBs Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 15, 2021

ALINITY c Albumin BCG Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

ALINITY c Cholesterol Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

ALINITY c Magnesium Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

ALINITY c Microalbumin Calibrators

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

ARCHITECT Anti-HBs Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2021

ALINITY c Creatinine Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2021

ARCHITECT Anti-HBs Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2021

ALINITY c Triglyceride Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS IS PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2021

ARCHITECT HAVAb-IgG Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2021

Microalbumin Controls

Manufacturer:

FISHER DIAGNOSTICS IS PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2021

ALINITY c Lactate Dehydrogenase Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2021

ALINITY i T-Uptake Calibrators

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2021

ALINITY i HBsAg Qualitative II Confirmatory Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 5, 2021

ARCHITECT HAVAb-IgG Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2021

ALKALINE Phosphatase

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2021

ALINITY i CMV IgG Avidity Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2021

ALINITY c Alkaline Phosphatase Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2021

ARCHITECT HBeAg Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2021

ALINITY i Cyclosporine Whole Blood Precipitation Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2021

SUPERA Peripheral Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 26, 2021

ALINITY c Carbon Dioxide Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

ALINITY i Multi-Assay Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

ALINITY i 25-OH Vitamin D Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2021

ALINITY c Transferrin Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2021

ALINITY i Anti-HBs Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 18, 2021

ALINITY i HBsAg Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2021

ALINITY i HBsAg Confirmatory V.1 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2021

ALINITY i HBsAg Confirmatory V.1 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

ALINITY c Uric Acid Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2021

ALINITY c Gamma-Glutamyl Transferase Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2021

ALINITY c-series Acid Probe Wash

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 21, 2021

ALINITY i Free T4 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2021

ALINITY i Total T4 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2021

Alinity i Estradiol Manual Diluent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2021

ALINITY i TSH Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2021

ALINITY i Free T3 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2021

ALINITY i Total T3 Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 18, 2021

ALINITY i CMV IgM Calibrator

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2021

ALINITY i HBsAg Confirmatory V.1 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2021

ALINITY i AFP Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2021

ALINITY i HBsAg Qualitative II Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2021

ALINITY i HBsAg Qualitative II Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2021

ARCHITECT HAVAb-IgM Controls

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2021

ALINITY i HBsAg Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2021

ARCHITECT HAVAb-IgM Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2021

ALINITY i HBsAg Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2021

ALINITY i Ferritin Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2021

ALINITY i Anti-HBs Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

ALINITY i Anti-HBs Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

ARCHITECT B.R.A.H.M.S PCT Controls

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

ALINITY i HBsAg Qualitative II Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 4, 2021

ALINITY i-series Concentrated Wash Buffer

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISON.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 3, 2021

ALINITY i Total β-hCG Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2021

ALINITY i Cortisol Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2021

ALINITY i Total T3 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2021

ALINITY i SARS-CoV-2 IgG II Quant Control Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2021

ARCHITECT B.R.A.H.M.S PCT Calibrators

Manufacturer:

Fisher Diagnostics, A Div. of Fisher Scientific Company, LLC, A Part of Thermo Fisher Scientific, Inc

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2021

ALINITY i AFP Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2021

ALINITY i AFP Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2021

ALINITY i 25-OH Vitamin D Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 27, 2021

ALINITY i Rubella IgM Calibrator

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 27, 2021

ALINITY i Rubella IgM Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2021

ALINITY i Processing Module

Manufacturer:

SANMINA-SCI SYSTEMS SINGAPORE PTE. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2021

ALINITY i CEA Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2021

ALINITY c IgE Standard

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2021

ALINITY in CMV IgM Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2021

ALINITY i CEA Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2021

ALINITY i CEA Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 18, 2021

ALINITY i SARS-CoV-2 IgG II Quant Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2021

ALINITY i Rubella IgG Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2021

ALINITY i Free T3 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2021

ALINITY i CMV IgM Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2021

ALINITY i CMV IgG Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2021

ALINITY i CMV IgG Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2021

ALINITY i Rubella IgG Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2021

ALINITY i Rubella IgM Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2021

ALINITY i Estradiol Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2021

ALINITY i Free T3 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2021

ALINITY i Estradiol Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2021

ALINITY i CMV IgG Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 5, 2021

ALINITY i Total T3 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2021

ALINITY i Estradiol Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2021

ARCHITECT c4000 Processing Module and Accessories

Manufacturer:

CANON MEDICAL SYSTEMS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2021

ALINITY i Total T4 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2021

ALINITY i Ferritin Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISON.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 23, 2021

ALINITY i 25-OH Vitamin D Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 23, 2021

ALINITY i Free T4 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 23, 2021

ALINITY i Free T4 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 23, 2021

ALINITY i Ferritin Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 23, 2021

ALINITY i Prolactin Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

ALINITY i Total T4 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

ALINITY i Total B-hCG Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

ARCHITECT FSH Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

ALINITY c-series Detergent B

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 18, 2021

ARCHITECT FSH Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2021

ALINITY c Apolipoprotein B

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2021

ALINITY c Aspartate Aminotransferase Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2021

ABBOTT ICT Sample Diluent

Manufacturer:

ABBOTT LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2021

ALINITY c Amylase Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2021

ALINITY c-series Alkaline Wash

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 30, 2021

ALINITY c-series Detergent A

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 30, 2021

ALINITY c-series Acid Wash

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 27, 2021

ALINITY c Total Protein Reagent Kit

Manufacturer:

FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2021

ARCHITECT i1000 SR Integrated Module and Accessories

Manufacturer:

FLEXTRONICS MANUFACTURING PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

ARCHITECT c4000 Processing Module and Accessories (Integrated)

Manufacturer:

CANON MEDICAL SYSTEMS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

ALINITY i Anti HCV Reagent Kit

Manufacturer:

ABBOTT GMBH & CO. Medical history

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2021

ALINITY i Anti-HCV Calibrator

Manufacturer:

ABBOTT GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

ALINITY i Anti-HCV Controls

Manufacturer:

ABBOTT GMBH & CO. KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

ALINITY c Microalbumin Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2021

ABBOTT Lipase

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2021

ALINITY c Microalbumin Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2021

ALINITY c Microalbumin

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 28, 2021

ABBOTT Microalbumin Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2021

ALINITY i Processing Module and Accessories

Manufacturer:

SANMINA-SCI SYSTEMS, PTE., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2021

ABBOTT Microalbumin Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

ABBOTT Apolipoprotein A1

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

ALINITY i STAT High Sensitive Troponin-I Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

ACCELERATOR a3600 and Accessories

Manufacturer:

INPECO S.P.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 5, 2021

ALINITY c Immunoglobulin G

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

ALINITY c Apolipoprotein A1

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

ABBOTT Prealbumin

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

CELL DYN 26 Plus Control

Manufacturer:

LINE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

ARCHITECT Tacrolimus Whole Blood Precipitation Reagent

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2021

ARCHITECT i1000 SR Processing Module and Accessories

Manufacturer:

FLEXTRONICS MANUFACTURING PTE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

ABBOTT Apolipoprotein B

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

ARCHITECT Sirolimus Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS INC .

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2021

ALINITY c Prealbumin

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2021

ALINITY i SARS-CoV-2 IgM Control Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2021

ALINITY i SARS-CoV-2 IgG Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2021

ALINITY c Haptoglobin

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

ALINITY c Complement C4

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

ALINITY i SARS-CoV-2 IgM Calibrator Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

ARCHITECT Sirolimus Whole Blood Precipitation Reag

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 21, 2021

ARCHITECT Sirolimus Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC .

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 21, 2021

ABBOTT Rheumatoid Factor

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2021

CELL DYN Emerald

Manufacturer:

BIT ANALYTICAL INSTRUMENTS GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2021

ALINITY c Immunoglobulin A

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2021

ALINITY c Uric Acid2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2021

ALINITY c Immunoglobulin M

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2021

SENTINEL Pancreatic Amylase

Manufacturer:

SENTINEL CH, S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2021

SENTINEL Iron

Manufacturer:

Sentinel CH. SPA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2021

ALINITY c Complement C3

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2021

ICT Module

Manufacturer:

CANON MEDICAL SYSTEMS CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 13, 2021

Alinity c Total Protein2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2021

CELL-DYN 18 Plus Control

Manufacturer:

LINE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 9, 2021

ABBOTT Cholesterol2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2021

ABBOTT Albumin BCG2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2021

ALINITY Albumin BCP2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2021

ARCHITECT AFP Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2021

ARCHITECT AFP Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2021

ALINITY Pre-Trigger Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2021

ALINITY Trigger Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 4, 2021

ABBOTT SARS-CoV-2 IgG Control Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2021

ALINITY i HBsAg Next Confirmatory Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 19, 2021

ABBOTT Immunoglobulin M

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2021

ABBOTT Immunoglobulin G

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2021

ABBOTT Uric Acid2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2021

ABBOTT Creatinine2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2021

ABBOTT Complement C3

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2021

ABBOTT Transferrin

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 8, 2021

ALINITY c Transferrin

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

ABBOTT Complement C4

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

ABBOTT Immunoglobulin A

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

ABBOTT Magnesium

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

ABBOTT Albumin BCP2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

ALINITY i HBsAg Next Qualitative Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jan 4, 2021

ABBOTT Haptoglobin

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

ALINITY c Magnesium

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2021

ALINITY i Anti-HCV Reagent Kit

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 22, 2020

ALINITY i Tacrolimus Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2020

ALINITY i Sirolimus Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2020

ALINITY i HBsAg Next Qualitative Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2020

ALINITY i HBsAg Next Confirmatory Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 20, 2020

ABBOTT Total Protein2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2020

ABBOTT Urea Nitrogen2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2020

ALINITY i Thyroglobulin Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2020

ALINITY i Thyroglobulin Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2020

ALINITY i Thyroglobulin Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2020

ALINITY i HBsAg Next Qualitative Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2020

ALINITY i Sirolimus Whole Blood Precipitation Reagent

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2020

ABBOTT Cholesterol2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

Alinity i Anti-HCV Calibrator

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

ALINITY i Anti-HCV Controls

Manufacturer:

ABBOTT GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2020

ARCHITECT Progesterone Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISON.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2020

ARCHITECT Total T4 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2020

CELL-DYN Emerald 22 Easy Cleaner

Manufacturer:

AVANTOR PERFORMANCE MATERIALS S.A.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 12, 2020

CELL-DYN Immuno PLT (CD61)

Manufacturer:

BD BIOSCIENCES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2020

CELL-DYN Immuno T-Cell (CD3/4/8) Reagents

Manufacturer:

BD BIOSCIENCES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2020

ABBOTT 20/30 Priority Pack Accessory Kit with .115" RHV

Manufacturer:

AVAILMED S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2020

ABBOTT 20/30 Priority Pack Accessory Kit with .096

Manufacturer:

AVAILMED S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2020

HI-TORQUE Balance Middleweight Elite Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 14, 2020

ABBOTT 20/30 INDEFLATOR Inflation Device

Manufacturer:

AVAILMED S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2020

MINI TREK RX Coronary Dilatation Catheter

Manufacturer:

ABBOTT VACULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2020

NC TREK RX Coronary Dilatation Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 10, 2020

XIENCE PRIME SV Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 24, 2020

Alinity s HBsAg Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 10, 2020

ALINITY s HBsAg Confirmatory Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 9, 2020

ACCELERATOR p540 Aliquoter Module and Accessories

Manufacturer:

A&T CORPORATION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 8, 2020

ABBOTT Immunoglobulin G

Manufacturer:

FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY LLC A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2020

ABBOTT Immunoglobulin M

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 17, 2020

Alinity s HBsAg Calibrator Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2020

ABBOTT Immunoglobulin A

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2020

RX HERCULINK ELITE Peripheral Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 8, 2020

ALINITY s HBsAg Assay Control Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2020

ALINITY s HBsAg Release Control Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2020

ABBOTT Apolipoprotein B

Manufacturer:

FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY LLC A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2020

ABBOTT Complement C3

Manufacturer:

FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY LLC A PART OF THERMO FISHER SCIENTIFIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2020

ABBOTT Apolipoprotein A1

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2020

HI-TORQUE Connect Flex Guide Wire

Manufacturer:

LAKE REGION MEDICAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 2, 2020

HI-TORQUE Supra Core 35 Guide Wire

Manufacturer:

ABBOTT VASCULAR.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 2, 2020

ABBOTT Complement C4

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2020

OMNILINK ELITE Peripheral Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 1, 2020

HI-TORQUE Connect 250T Guide Wire

Manufacturer:

LAKE REGION MEDICAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2020

Prealbumin

Manufacturer:

FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2020

HI-TORQUE Connect Guide Wire

Manufacturer:

LAKE REGION MEDICAL LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2020

20/30 PRIORITY PACK with COPILOT Bleedback Control Valve

Manufacturer:

AVAILMED S.A. DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2020

XIENCE PRIME LL Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 12, 2019

XIENCE PRIME Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 12, 2019

XIENCE PRO X Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 12, 2019

XIENCE PRIME BTK EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 10, 2019

AMOUNT Myoglobin

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2019

MULTI-LINK 8 SV Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 25, 2019

MULTI-LINK 8 LL Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 25, 2019

MULTI-LINK 8 Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 19, 2019

STARCLOSE SE Vascular Closure System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 19, 2019

XIENCE Xpedition SV Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 19, 2019

XIENCE Xpedition LL Everolimus Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 19, 2019

HI-TORQUE Progress 40 Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 12, 2019

HI-TORQUE Progress 80 Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 12, 2019

HI-TORQUE Extra S'port Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 5, 2019

ARCHITECT ProGRP Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2019

ARCHITECT Pro GRP Controls

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2019

MINI TREK II OTW Coronary Dilatation Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 17, 2019

COPILOT BleedBack Control Valve

Manufacturer:

AVAILMED S.A DE C.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2019

ARCHITECT Insulin Reagent

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2019

ARCHITECT Insulin Controls

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2019

ARCHITECT Insulin Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2019

ABBOTT Ultra HDL

Manufacturer:

ABBOTT LABORATORIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2019

ALINITY c A-1-AGP Reagent Kit

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2019

ALINITY c β2-Microglobulin Standard

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2019

ALINITY c β2-Microglobulin Reagent Kit

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2019

ALINITY c A1-Antitrypsin Reagent Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2019

ARCHITECT Pre-Trigger Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2019

ARCHITECT Anti-HCV Reagent Kit

Manufacturer:

ABBOTT GMBH & CO. KG.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 29, 2019

ARCHITECT BNP Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2019

ARCHITECT SHBG Calibrators

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 11, 2019

ABBOTT Triglyceride

Manufacturer:

ABBOTT LABORATORIES

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 11, 2019

ALINITY i Insulin Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 11, 2019

ARCHITECT SHBG Controls

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2019

ARCHITECT SHBG Reagent Kit

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2019

BIOKIT Lp (a) Control

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 18, 2019

ALINITY c-series Detergent B

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 18, 2019

ALINITY i Insulin Controls

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2019

ALINITY i Insulin Reagent Kit

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2019

QUANTIA Ferritin / Myoglobin / IgE Control

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2019

ARCHITECT Cyclosporin Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025