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PT. ABBOTT PRODUCTS INDONESIA

Indonesia941 products represented137 manufacturers
VerifiedKemenkes (Ministry of Health) · official registry
941
Total Products
137
Manufacturers
3
Product Classes
4
Risk Classes
Registered address
Address
Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
Regulatory footprint
Search PT. ABBOTT PRODUCTS INDONESIA across other regulatory registries
Risk classification breakdown
Distribution of represented products across risk classes
Kelas Resiko : A353.7% of total
Kelas Resiko : B66871.0% of total
Kelas Resiko : C18719.9% of total
Kelas Resiko : D515.4% of total
Manufacturer portfolio
Products organized by manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Ireland
164 Products
ABBOTT IRELAND DIAGNOSTICS DIVISION
Ireland
105 Products
ABBOTT GMBH
Germany
54 Products
ABBOTT VASCULAR
United States
46 Products
FUJIREBIO DIAGNOSTICS, INC
United States
31 Products
BIOKIT, S.A.
Spain
29 Products
ABBOTT GMBH.
Germany
27 Products
BIOKIT S.A.
Spain
22 Products
FUJIREBIO DIAGNOSTICS INC.
United States
19 Products
MICROGENICS CORPORATION
United States
18 Products
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
United States
17 Products
BIOKIT, S.A
Spain
16 Products
ABBOTT MOLECULAR, INC.
United States
15 Products
FUJIREBIO DIAGNOSTICS, INC.
United States
14 Products
SEKISUI DIAGNOSTICS P.E.I. INC.
Canada
14 Products
SENTINEL CH. S.P.A.
Italy
13 Products
DENKA SEIKEN CO., LTD.
Japan
13 Products
SENTINEL CH. SPA.
Italy
12 Products
AXIS-SHIELD DIAGNOSTICS LIMITED
United Kingdom
12 Products
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.
United States
12 Products
DENKA CO., LTD.
Japan
11 Products
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.
United States
11 Products
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC
United States
11 Products
ABBOTT GmbH
Germany
10 Products
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.
United States
9 Products
DENKA, CO. LTD
Japan
9 Products
TECHNOPATH MANUFACTURING LTD.
Ireland
9 Products
LINE.
United States
7 Products
MICROGENICS CORPORATION.
United States
7 Products
ABBOTT LABORATORIES.
United States
6 Products
Axis-Shield Diagnostics Limited
United Kingdom
6 Products
BIOKIT S.A
Spain
6 Products
SENTINEL CH, SPA.
Italy
6 Products
SENTINEL CH., SPA.
Italy
5 Products
ABBOTT LABORATORIES
United States
5 Products
SENTINEL CH. S.P.A
Italy
5 Products
SEKISUI DIAGNOSTICS P.E.I INC.
Canada
5 Products
ABBOTT DIABETES CARE LTD.
United Kingdom
4 Products
ABBOTT IRELAND DIAGNOSTICS DIVISON.
Ireland
4 Products
CANON MEDICAL SYSTEMS CORPORATION.
Japan
4 Products
FISHER DIAGNOSTICS IS PART OF THERMO FISHER SCIENTIFIC, INC.
United States
4 Products
ABBOTT MEDICAL (MENLO PARK)
United States
3 Products
ABBOTT VASCULAR.
Puerto Rico USA
3 Products
SEKISUI DIAGNOSTICS P.E.I INC
Canada
3 Products
FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.
United States
3 Products
FUJIREBIO DIAGNOSTICS INC
United States
3 Products
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC
United States
3 Products
FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC
United States
3 Products
SENTINEL CH SPA.
Italy
3 Products
AXIS-SHIELD DIAGNOSTICS LIMITED.
United Kingdom
3 Products
CLINICAL DIAGNOSTIC SOLUTIONS
United States
3 Products
AXIS SHIELD DIAGNOSTICS LTD.
United Kingdom
3 Products
ABBOTT GMBH & CO. KG.
Germany
3 Products
AVAILMED S.A DE C.V.
Mexico
3 Products
FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY LLC A PART OF THERMO FISHER SCIENTIFIC, INC.
United States
3 Products
LAKE REGION MEDICAL LIMITED
Ireland
3 Products
RANDOX LABORATORIES, LTD
United Kingdom
2 Products
AVANTOR PERFORMANCE MATERIALS S.A.
Poland
2 Products
SANMINA-SCI SYSTEMS SINGAPORE PTE LTD
Singapore
2 Products
BIT GROUP FRANCE
France
2 Products
SENTINEL CH., S.P.A.
Italy
2 Products
FLEXTRONICS MEDICAL DEVICE MANUFACTURING (SHENZHEN) CO., LTD.
China
2 Products
SEKISUI DIAGNOSTICS P.E.I, INC
Canada
2 Products
FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC
United States
2 Products
SEKISUI DIAGNOSTICS P.E.I., INC.
Canada
2 Products
SENTINEL CH. SPA
Italy
2 Products
FLEXTRONICS MANUFACTURING (SINGAPORE) PTE., LTD.
Singapore
2 Products
TECHNO-PATH MANUFACTURING LTD.
Ireland
2 Products
SEKISUI DIAGNOSTICS P.E.I. INC
Canada
2 Products
DENKA SEIKEN CO.,LTD
Japan
2 Products
FLEXTRONICS MANUFACTURING PTE LTD
Singapore
2 Products
FUJIREBIO DIAGNOSTICS INC .
United States
2 Products
BD BIOSCIENCES.
United States
2 Products
AVAILMED S.A. DE C.V.
Mexico
2 Products
ABBOTT MEDICAL. (Menlo park)
United States
1 Products
BIT ANALYTICAL INSTRUMENTS GMBH.
Germany
1 Products
ABBOTT VASCULAR COSTA RICA
Costa Rica
1 Products
ABBOTT VASCULAR, TEMEUCULA
United States
1 Products
TECHNO-PATH MANUFACTURING LTD
Ireland
1 Products
FISHER DIAGNOSTICS A DIV. OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC INC.
United States
1 Products
DENKA SEIKEN CO., LTD
Japan
1 Products
AUG. HEDINGER GMBH & CO. KG.
Germany
1 Products
Fujirebio Diagnostics, Inc.
United States
1 Products
BIONOSTICS INC.
United States
1 Products
LINE
United States
1 Products
FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC
United States
1 Products
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC.
United States
1 Products
FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC.
United States
1 Products
FISHER DIAGNOSTICS, A DIV. OF FISHER SCIENTIFIC COMPANY,LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.,
United States
1 Products
ABBOTT GMBH,
Germany
1 Products
FACET TECHNOLOGIES, LLC.
United States
1 Products
FISHER DIAGNOSTICS, A DIV . OF FISHER SCIENTIFIC COMPANY,LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.,
United States
1 Products
FISHER DIAGNOSTICS, A DIV . OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC, INC.,
United States
1 Products
NITTOBO MEDICAL CO. LTD., MEDICAL DEVELOPMENT CENTER
Japan
1 Products
NITTOBO MEDICAL CO., LTD MEDICAL DEVELOPMENT CENTER
Japan
1 Products
STRECK LLC
United States
1 Products
FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC
United States
1 Products
FISHER DIAGNOSTICS A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC.
United States
1 Products
AVANTOR PERFORMANCE MATERIALS POLAND S.A.
Poland
1 Products
AVANTOR PERFORMANCE MATERIALS POLAND S.A
Poland
1 Products
TECHNO-PATH MANUFACTURING, LTD
Ireland
1 Products
TECHNOPATH MANUFACTURING, LTD.
Ireland
1 Products
BIT ANALYTICAL INSTRUMENTS
Germany
1 Products
RANDOX LABORATORIES, LTD.
United Kingdom
1 Products
FISHER DIAGNOSTICS,A DIVISION OF FISHER SCIENTIFIC COMPANY LLC, A PART OF THERMO FISHER SCIENTIFIC INC.
United States
1 Products
BIOKIT, S.A.,
Spain
1 Products
ABBOTT IRELAND DIAGNOSTIC DIVISION.
Ireland
1 Products
FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.
United States
1 Products
FISHER DIAGNOSTICS.
United States
1 Products
DENKA CO.,LTD
Japan
1 Products
SEKISUI DIAGNOSTICS P.E.I, INC.
Canada
1 Products
Fisher Diagnostics, A Div. Of Fisher Scientific Company, LLC A Part Of Thermo Fisher Scientific, Inc.
United States
1 Products
SENTINEL CH S.P.A.
Italy
1 Products
CANON MEDICAL SYSTEMS CORPORATION
Japan
1 Products
ABBOTT S.R.L.
Italy
1 Products
NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER.
Japan
1 Products
SENTINEL CH. S.PA.
Italy
1 Products
FISHER DIAGNOSTICS A DIV . OF FISHER SCIENTIFIC COMPANY, LLC A PART OF THERMO FISHER SCIENTIFIC, INC.
United States
1 Products
SANMINA-SCI SYSTEMS.
Singapore
1 Products
Abbott GmbH
Germany
1 Products
SENTINEL CH, S.P.A..
Italy
1 Products
Sentinel CH. SpA
Italy
1 Products
CLINICAL DIAGNOSTIC SOLUTION INC.
United States
1 Products
FLEXTRONICS MANUFACTURING PTE. LTD.
Singapore
1 Products
AXIS-SHIELD DIAGNOSTICS LTD.
United Kingdom
1 Products
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC
United States
1 Products
Fisher Diagnostics, A Div. of Fisher Scientific Company, LLC, A Part of Thermo Fisher Scientific, Inc
United States
1 Products
SANMINA-SCI SYSTEMS SINGAPORE PTE. LTD
Singapore
1 Products
ABBOTT GMBH & CO. Medical history
Germany
1 Products
SANMINA-SCI SYSTEMS, PTE., LTD.
Singapore
1 Products
INPECO S.P.A.
Italy
1 Products
BIT ANALYTICAL INSTRUMENTS GMBH
Germany
1 Products
SENTINEL CH, S.P.A.
Italy
1 Products
Sentinel CH. SPA.
Italy
1 Products
ABBOTT VACULAR
Costa Rica
1 Products
A&T CORPORATION.
Japan
1 Products
FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC
United States
1 Products
All represented products (941)
Complete portfolio registered with Ministry of Health
ARCHITECT Total T4 Reagent Kit
Feb 10, 2025
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Lactate Dehydrogenase2
Feb 10, 2025
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Amylase2
Feb 10, 2025
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Consolidated Chemistry Calibrator
Feb 7, 2025
Manufacturer
RANDOX LABORATORIES, LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Total T4 Controls
Feb 6, 2025
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
MITRACLIP G4 NTW Clip Delivery System
Feb 6, 2025
Manufacturer
ABBOTT MEDICAL (MENLO PARK)
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ABBOTT Amylase2
Feb 4, 2025
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
MITRACLIP G4 Steerable Guide Catheter
Feb 4, 2025
Manufacturer
ABBOTT MEDICAL. (Menlo park)
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL-DYN Emerald 22 Diluent
Feb 3, 2025
Manufacturer
AVANTOR PERFORMANCE MATERIALS S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Lactate Dehydrogenase2
Feb 1, 2025
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY hs Slide Maker Stainer Module and Accessories
Feb 1, 2025
Manufacturer
SANMINA-SCI SYSTEMS SINGAPORE PTE LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY hq Analyzer and Accessories
Feb 1, 2025
Manufacturer
SANMINA-SCI SYSTEMS SINGAPORE PTE LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
SUPERA Peripheral Stent System
Jan 23, 2025
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Ammonia Controls
Jan 8, 2025
Manufacturer
SENTINEL CH., SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Processing Module and Accessories
Jan 6, 2025
Manufacturer
ABBOTT LABORATORIES
Class
Kelas : 2
Risk Class
Kelas Resiko : B
MITRACLIP G4 XTW Clip Delivery System
Jan 2, 2025
Manufacturer
ABBOTT MEDICAL (MENLO PARK)
Class
Kelas : 3
Risk Class
Kelas Resiko : D
MITRACLIP G4 NT Clip Delivery System
Jan 2, 2025
Manufacturer
ABBOTT MEDICAL (MENLO PARK)
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i Rubella IgG Reagent Kit
Dec 30, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Syphilis TP Reagent Kit
Dec 27, 2024
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c D-Dimer Controls
Dec 27, 2024
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c D-Dimer
Dec 23, 2024
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Rubella IgG Reagent Kit
Dec 23, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL-DYN Emerald 22 and Accessories
Dec 23, 2024
Manufacturer
BIT ANALYTICAL INSTRUMENTS GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Diluent / Sheath (Cell-Dyn Sapphire and Cell-Dyn Ruby Systems
Dec 19, 2024
Manufacturer
ABBOTT LABORATORIES.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c TDM Multiconstituent Calibrator Kit
Dec 17, 2024
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN 22 Plus Calibrator
Dec 13, 2024
Manufacturer
LINE.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Carbamazepine Reagent Kit
Dec 13, 2024
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN 22 Plus Control
Dec 13, 2024
Manufacturer
LINE.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Emerald 22 Lyse
Dec 11, 2024
Manufacturer
BIT GROUP FRANCE
Class
Kelas : 2
Risk Class
Kelas Resiko : B
MINI TREK RX Coronary Dilatation Catheter
Dec 10, 2024
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
SENTINEL Ammonia Ultra
Dec 2, 2024
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARMADA 35 LL PTA Catheter
Nov 28, 2024
Manufacturer
ABBOTT VASCULAR COSTA RICA
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT HCV Ag Reagent Kit
Nov 26, 2024
Manufacturer
DENKA CO., LTD.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
TREK RX Coronary Dilatation Catheter
Nov 26, 2024
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
VIATRAC 14 Plus Peripheral Dilatation Catheter
Nov 25, 2024
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABSOLUTE PRO Peripheral Self-Expanding Stent System
Nov 25, 2024
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Active-B12 (Holotranscobalamin) Reagent Kit
Nov 22, 2024
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT PIVKA-II Calibrators
Nov 22, 2024
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Active-B12 (Holotranscobalamin) Controls
Nov 22, 2024
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c D-Dimer Calibrator
Nov 22, 2024
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Active-B12 (Holotranscobalamin) Controls
Nov 22, 2024
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARMADA 14 PTA Catheter
Nov 21, 2024
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Active-B12 (Holotranscobalamin) Calibrators
Nov 20, 2024
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Albumin BCG2
Nov 20, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Active-B12 (Holotranscobalamin) Calibrators
Nov 20, 2024
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit
Nov 20, 2024
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN 29 Plus Control (with retic)
Nov 20, 2024
Manufacturer
LINE.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
EMBOSHIELD NAV6 Embolic Protection System
Nov 19, 2024
Manufacturer
ABBOTT VASCULAR, TEMEUCULA
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Anti-HBc IgM Calibrators
Nov 19, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CK-MB Control
Nov 18, 2024
Manufacturer
SENTINEL CH., S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Consolidated Chemistry Calibrator
Nov 14, 2024
Manufacturer
RANDOX LABORATORIES, LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i PIVKA-II Reagent Kit
Nov 14, 2024
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
TECHNOPATH Multichem hsTn
Nov 12, 2024
Manufacturer
TECHNO-PATH MANUFACTURING LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABSOLUTE PRO LL Peripheral Self-Expanding Stent System
Nov 11, 2024
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
FREESTYLE Optium Neo H Blood Glucose and Ketone Monitoring System
Nov 11, 2024
Manufacturer
FLEXTRONICS MEDICAL DEVICE MANUFACTURING (SHENZHEN) CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Bilirubin Calibrator
Nov 9, 2024
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
FREESTYLE Optium Neo H Blood Glucose Test Strips
Nov 9, 2024
Manufacturer
ABBOTT DIABETES CARE LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c CRP Vario HS Control Kit
Nov 9, 2024
Manufacturer
SENTINEL CH. S.P.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Cyclosporine Calibrators
Nov 9, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CRP Control HS
Nov 6, 2024
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
X.ACT Carotid Stent System
Nov 6, 2024
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
FREESTYLE Optium H Blood β Ketone Test Strips
Nov 1, 2024
Manufacturer
ABBOTT DIABETES CARE LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HBc IgM Controls
Nov 1, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Cyclosporine Calibrators
Nov 1, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CK-MB Calibrator
Nov 1, 2024
Manufacturer
SENTINEL CH., S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HBc IgM Reagent Kit
Oct 30, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i Cyclosporine Reagent Kit
Oct 30, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Cyclosporine Reagent Kit
Oct 25, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT 25-OH Vitamin D Reagent Kit
Oct 25, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
FREESTYLE Optium Neo Blood Glucose and Ketone Monitoring System
Oct 25, 2024
Manufacturer
FLEXTRONICS MEDICAL DEVICE MANUFACTURING (SHENZHEN) CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Calcium2
Oct 21, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT 25-OH Vitamin D Controls
Oct 21, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Phosphorus Reagent Kit
Oct 16, 2024
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
ALINITY c-series Acid Wash
Oct 14, 2024
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
ALINITY c Lithium Reagent Kit
Oct 14, 2024
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT SCC Controls
Oct 11, 2024
Manufacturer
DENKA SEIKEN CO., LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HAVAb-IgM Reagent Kit
Oct 11, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY h-series AutoClean Solution
Oct 9, 2024
Manufacturer
AUG. HEDINGER GMBH & CO. KG.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ARCHITECT Free T4 Reagent Kit
Oct 9, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
HI-TORQUE Command Guide Wire
Oct 7, 2024
Manufacturer
ABBOTT VASCULAR.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT BNP Calibrators
Oct 7, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT 25-OH Vitamin D Calibrators
Oct 7, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CA 19-9XR Controls
Oct 1, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i BNP Calibrators
Oct 1, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CA 19-9XR Reagent Kit
Oct 1, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CA 19-9XR Calibrators
Oct 1, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 19-9XR Reagent Kit
Oct 1, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 125 II Controls
Sep 27, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 125 II Reagent Kit
Sep 24, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 19-9 XR Controls
Sep 24, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 125 II Calibrators
Sep 19, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 19-9 XR Calibrators
Sep 19, 2024
Manufacturer
Fujirebio Diagnostics, Inc.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
FREESTYLE Optium Blood Glucose Test Strips
Sep 5, 2024
Manufacturer
ABBOTT DIABETES CARE LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT Folate Lysis Reagent
Aug 28, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Folate Lysis Reagent
Aug 28, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT STAT High Sensitive Troponin-I Calibrators
Aug 26, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i STAT High Sensitive Troponin-I Calibrators
Aug 26, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i STAT High Sensitive Troponin-I Controls
Aug 26, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Folate RBC Lysis Diluent
Aug 26, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c-series ICT Reference Solution
Aug 21, 2024
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
ALINITY c Urine/CSF Protein Calibrator Kit
Aug 21, 2024
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
ARCHITECT Free PSA Calibrators
Aug 19, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
MEDISENSE Glucose & Ketone Control Solutions
Aug 14, 2024
Manufacturer
BIONOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY Trigger Solution
Aug 14, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ARCHITECT Folate RBC Lysis Diluent
Aug 13, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Free PSA Controls
Aug 8, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Pre-Trigger Solution
Aug 8, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY h-series Hemcal
Aug 8, 2024
Manufacturer
LINE.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBeAg Quantitative Calibrators
Aug 8, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity c Alanine Aminotransferase Reagent Kit
Aug 8, 2024
Manufacturer
SEKISUI DIAGNOSTICS P.E.I, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c ICT Serum Calibrator Kit
Aug 8, 2024
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
ALINITY c ASO Reagent Kit
Aug 8, 2024
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY Pre-Trigger Solution
Aug 8, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY c Creatine Kinase Reagent Kit
Aug 8, 2024
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
HI-TORQUE Command ES Guide Wire
Aug 7, 2024
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
HI-TORQUE Command 18 ST Guide Wire
Aug 7, 2024
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Trigger Solution
Aug 4, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY i CA 125 II Reagent Kit
Aug 4, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i HE4 Reagent Kit
Aug 4, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CA 125 II Calibrators
Aug 4, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i HE4 Calibrators
Aug 4, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i HE4 Controls
Aug 4, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CA 125 II Controls
Jul 31, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Rubella IgG Controls
Jul 31, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
FREESTYLE Optium Blood β-Ketone Test Strips
Jul 30, 2024
Manufacturer
ABBOTT DIABETES CARE LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Rubella IgG Calibrators
Jul 30, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c Urine / CSF Protein Reagent Kit
Jul 30, 2024
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
ALINITY c Digitoxin Reagent Kit
Jul 29, 2024
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Digitoxin Standard
Jul 29, 2024
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Syphilis TP Reagent Kit
Jul 29, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY h-series Control 29P
Jul 29, 2024
Manufacturer
LINE
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Digitoxin Controls
Jul 25, 2024
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBeAg Quantitative Controls
Jul 25, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Multiconstituent Calibrator Kit
Jul 24, 2024
Manufacturer
MICROGENICS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Syphilis TP Controls
Jul 11, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Tacrolimus Calibrators
Jul 9, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Tacrolimus Whole Blood Precipitation Reagent
Jul 9, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Syphilis TP Calibrator
Jul 9, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Syphilis TP Controls
Jul 9, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c Ultra HDL Reagent Kit
Jul 8, 2024
Manufacturer
SEKISUI DIAGNOSTICS P.E.I, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Bilirubin Calibrator Kit
Jul 4, 2024
Manufacturer
MICROGENICS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Calcium Reagent Kit
Jul 4, 2024
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
ALINITY c ICT Urine Calibrator Kit
Jul 4, 2024
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HCV Reagent Kit
Jul 4, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY c Carbon Dioxide Calibrator Kit
Jul 4, 2024
Manufacturer
MICROGENICS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Syphilis TP Calibrator
Jul 3, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c Direct Bilirubin Reagent Kit
Jul 3, 2024
Manufacturer
SEKISUI DIAGNOSTICS P.E.I INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Hemoglobin A1c Controls
Jun 28, 2024
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Hemoglobin A1c Reagent Kit
Jun 28, 2024
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Hemoglobin A1c Calibrators
Jun 24, 2024
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HCV Controls
Jun 24, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HCV Calibrator
Jun 20, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HAVAb IgG Calibrator
Jun 19, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-Tg Reagent Kit
Jun 14, 2024
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
ALINITY i Anti-HBc II Calibrator
Jun 10, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HBc II Controls
Jun 10, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HBc II Reagent Kit
Jun 10, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i HIV Ag/Ab Combo Reagent Kit
Jun 10, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i HAVAb IgG Reagent Kit
Jun 7, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HAVAb IgG Controls
Jun 7, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c ICT Sample Diluent
Jun 7, 2024
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
ALINITY c Lactic Acid Reagent Kit
Jun 7, 2024
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
ALINITY i Prolactin Calibrators
Jun 7, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-Tg Calibrators
Jun 7, 2024
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
ALINITY c Urea Nitrogen Reagent Kit
Jun 7, 2024
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
ALINITY i HIV Ag/Ab Combo Controls
Jun 7, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HIV Ag/Ab Combo Calibrator
Jun 7, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i SCC Controls
Jun 4, 2024
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i SCC Reagent Kit
Jun 4, 2024
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-TPO Reagent Kit
Jun 3, 2024
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
ABBOTT Microalbumin
Jun 2, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Prolactin Controls
May 31, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT SCC Reagent Kit
May 30, 2024
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Toxo IgM Reagent Kit
May 29, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i BNP Reagent Kit
May 27, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Anti-Tg Controls
May 27, 2024
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
ARCHITECT BNP Reagent Kit
May 21, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Toxo IgG Avidity Reagent Kit
May 21, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Tacrolimus Whole Blood Precipitation Reagent
May 20, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Prolactin Calibrators
May 20, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Prolactin Controls
May 20, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Tacrolimus Calibrators
May 20, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Cortisol Calibrators
May 14, 2024
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
ALINITY i SCC Calibrators
May 14, 2024
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBc IgM Reagent Kit
May 13, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY and Toxo IgM Controls
May 8, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i HBeAg Controls
May 8, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Galectin-3 Reagent Kit
May 8, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Galectin-3 Calibrators
May 8, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Toxo IgG Avidity Controls
May 8, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Toxo IgM Calibrator
May 8, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Galectin-3 Controls
May 8, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Cortisol Reagent Kit
May 7, 2024
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
ARCHITECT HBeAg Reagent Kit
May 6, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ARCHITECT Anti-HBc IgM Controls
Apr 29, 2024
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i STAT CK-MB Calibrators
Apr 29, 2024
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
ALINITY i Anti-HBe Calibrator
Apr 26, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY and Toxo IgG Controls
Apr 25, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i HBeAg Calibrators
Apr 25, 2024
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HBe Controls
Apr 25, 2024
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HBeAg Quantitative Controls
Apr 24, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HAVAb-IgG Reagent Kit
Apr 24, 2024
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Progesterone Calibrators
Apr 16, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Progesterone Calibrators
Apr 16, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Progesterone Controls
Apr 16, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Progesterone Controls
Apr 16, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HIV Ag/Ab Combo Reagent Kit
Apr 7, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ARCHITECT Anti-HBc IgM Calibrators
Apr 5, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HIV Ag/Ab Combo Controls
Apr 5, 2024
Manufacturer
ABBOTT GMBH,
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-TPO Controls
Apr 5, 2024
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
ALINITY i Toxo IgG Calibrators
Apr 4, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT HBeAg Quantitative Calibrators
Apr 4, 2024
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Toxo IgG Reagent Kit
Apr 3, 2024
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT STAT CK-MB Calibrators
Apr 3, 2024
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
ALINITY i Anti TPO Calibrators
Mar 29, 2024
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
ALINITY i B.R.A.H.M.S PCT Controls
Mar 21, 2024
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
ALINITY i B.R.A.H.M.S PCT Calibrators
Mar 18, 2024
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
ALINITY i HAVAb IgM Reagent Kit
Mar 10, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CA 15-3 Controls
Mar 8, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Homocysteine Controls
Mar 6, 2024
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HBsAg Reagent Kit
Mar 6, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i CA 15-3 Calibrators
Mar 5, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT STAT CK-MB Controls
Mar 5, 2024
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Progesterone Reagent Kit
Mar 5, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CA 15-3 Controls
Mar 5, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 15-3 Reagent Kit
Mar 5, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CA 15-3 Calibrators
Mar 5, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
Alinity i HAVAb IgM Controls
Mar 5, 2024
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CA 15-3 Reagent Kit
Mar 5, 2024
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
FREESTYLE Lancets
Mar 5, 2024
Manufacturer
FACET TECHNOLOGIES, LLC.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ARCHITECT STAT Myoglobin Controls
Mar 4, 2024
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HIV Ag/Ab Combo Calibrator
Mar 1, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Homocysteine Calibrators
Mar 1, 2024
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HBsAg Calibrators
Mar 1, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i 2nd Generation Testosterone Controls
Feb 28, 2024
Manufacturer
Axis-Shield Diagnostics Limited
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i 2nd Generation Testosterone Calibrators
Feb 28, 2024
Manufacturer
Axis-Shield Diagnostics Limited
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity i 2nd Generation Testosterone Reagent Kit
Feb 28, 2024
Manufacturer
Axis-Shield Diagnostics Limited
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT 2nd Generation Testosterone Reagent Kit
Feb 27, 2024
Manufacturer
Axis-Shield Diagnostics Limited
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity i HAVAb IgM Calibrator
Feb 27, 2024
Manufacturer
ABBOTT GmbH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT STAT Myoglobin Calibrators
Feb 27, 2024
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
ARCHITECT HBsAg Qualitative II Controls
Feb 27, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT STAT Myoglobin Reagent Kit
Feb 27, 2024
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
ARCHITECT HBsAg Qualitative II Confirmatory Manual Diluent
Feb 26, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HBsAg Qualitative II Calibrators
Feb 26, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISON.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT 2nd Generation Testosterone Controls
Feb 25, 2024
Manufacturer
Axis-Shield Diagnostics Limited
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT 2nd Generation Testosterone Calibrators
Feb 21, 2024
Manufacturer
Axis-Shield Diagnostics Limited
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Quantia β2-Microglobulin
Feb 17, 2024
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Glucose Reagent Kit
Feb 13, 2024
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
Quantia β2-Microglobulin Standard
Feb 6, 2024
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Specific Proteins Multiconstituent Calibrator
Feb 6, 2024
Manufacturer
NITTOBO MEDICAL CO. LTD., MEDICAL DEVELOPMENT CENTER
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Quantia PROTEINS Control
Feb 4, 2024
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Total Bilirubin
Feb 1, 2024
Manufacturer
SEKISUI DIAGNOSTICS P.E.I., INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Prealbumin Calibrator
Feb 1, 2024
Manufacturer
NITTOBO MEDICAL CO., LTD MEDICAL DEVELOPMENT CENTER
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Quantia Ferritin Standard
Feb 1, 2024
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i GFAP Controls
Jan 27, 2024
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Folate Controls
Dec 29, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i UCH-L1 Controls
Dec 29, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Folate Controls
Dec 29, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Folate Calibrators
Dec 19, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Folate Calibrators
Dec 19, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
HI-TORQUE Winn Guide Wire
Dec 13, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c Iron Calibrator Kit
Dec 10, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Processing Module and Accessories
Dec 6, 2023
Manufacturer
CANON MEDICAL SYSTEMS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT i1000SR Integrated Module
Dec 4, 2023
Manufacturer
ABBOTT LABORATORIES
Class
Kelas : 2
Risk Class
Kelas Resiko : B
HI-TORQUE PILOT Guide Wire
Nov 29, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
SENTINEL Lipase NG OC Cal
Nov 28, 2023
Manufacturer
SENTINEL CH. SPA
Class
Kelas : 2
Risk Class
Kelas Resiko : B
SENTINEL Lipase NG OC CTRL 1
Nov 27, 2023
Manufacturer
SENTINEL CH. SPA
Class
Kelas : 2
Risk Class
Kelas Resiko : B
NSE Controls
Nov 27, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
SENTINEL Lipase NG OC Reagent Kit
Nov 27, 2023
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
NSE Calibrators
Nov 27, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
NSE Reagent Kit
Nov 27, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
SENTINEL Lipase NG OC CTRL 2
Nov 27, 2023
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN HemCal Plus Calibrator
Nov 17, 2023
Manufacturer
STRECK LLC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Galectin-3 Calibrators
Nov 16, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity i Galectin-3 Reagent Kit
Nov 13, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Galectin-3 Controls
Nov 13, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Pepsinogen I Controls
Nov 13, 2023
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Enzymatic Cleaner Concentrate
Nov 8, 2023
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
HI-TORQUE Winn 80 Guide Wire
Nov 6, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i STAT CK-MB Controls
Nov 6, 2023
Manufacturer
MICROGENICS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Pepsinogen II Calibrators
Oct 30, 2023
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Pepsinogen I Reagent Kit
Oct 30, 2023
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Pepsinogen II Controls
Oct 30, 2023
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Sirolimus Calibrators
Oct 30, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Pepsinogen I Calibrator
Oct 30, 2023
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
HI-TORQUE Pilot 150 Guide Wire with Hydrophilic Coating
Oct 26, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i STAT CK-MB Reagent Kit
Oct 26, 2023
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
GRAFTMASTER RX Coronary Stent Graft System
Oct 25, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i Sirolimus Reagent Kit
Oct 25, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i STAT Myoglobin Controls
Oct 23, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Ruby and Accessories
Oct 23, 2023
Manufacturer
FLEXTRONICS MANUFACTURING (SINGAPORE) PTE., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
RX Herculink Elite Peripheral Stent System
Oct 20, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Pepsinogen II Reagent Kit
Oct 19, 2023
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
QUANTIA RF Standard
Oct 19, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i STAT Myoglobin Reagent Kit
Oct 19, 2023
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
ASO Standard AMOUNT
Oct 18, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
Standard IgE Amount
Oct 15, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Ferritin/Myoglobin/IgE Control Kit
Oct 13, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
NC TREK NEO™ Coronary Dilation Catheter
Oct 11, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT Alinity m EBV AMP Kit
Oct 9, 2023
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT Alinity m EBV CTRL Kit
Oct 9, 2023
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT HBsAg Next Qualitative Controls
Oct 4, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT i1000 SR Processing Module and Accessories
Oct 4, 2023
Manufacturer
ABBOTT LABORATORIES
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Lp(a) Control
Sep 24, 2023
Manufacturer
BIOKIT S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
RF AMOUNT
Sep 22, 2023
Manufacturer
BIOKIT S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Anti-TPO Controls
Sep 20, 2023
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
ASO AMOUNT
Sep 20, 2023
Manufacturer
BIOKIT S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Cortisol Calibrators
Sep 18, 2023
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
QUANTIA D-Dimer Standard
Sep 18, 2023
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Amount D-Dimer Control
Sep 15, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Homocysteine Reagent Kit
Sep 14, 2023
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity h-series May-Grünwald-Giemsa Stain
Sep 14, 2023
Manufacturer
AVANTOR PERFORMANCE MATERIALS POLAND S.A.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
AMOUNT D-Dimer
Sep 14, 2023
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY h-series Wright-Giemsa Stain
Sep 14, 2023
Manufacturer
AVANTOR PERFORMANCE MATERIALS POLAND S.A
Class
Kelas : 1
Risk Class
Kelas Resiko : A
AMOUNT Ferritin
Sep 5, 2023
Manufacturer
BIOKIT S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
AMOUNT IgE
Sep 5, 2023
Manufacturer
BIOKIT S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c ASO-RF Control I Kit
Sep 3, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
TECHNOPATH Multichem WBT
Sep 2, 2023
Manufacturer
TECHNO-PATH MANUFACTURING, LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Myoglobin Standard
Sep 2, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Myoglobin Reagent Kit
Sep 2, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c ASO-RF Control II Kit
Aug 28, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Quantia Ferritin/Myoglobin/IgE Control
Aug 23, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
AMOUNT ASO-RF Control I
Aug 22, 2023
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Lp(a) Calibrators
Aug 22, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity c RF Reagent Kit
Aug 21, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c ASO Standard
Aug 21, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : C
AMOUNT Lp(a)
Aug 19, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Lp(a) Reagent Kit
Aug 17, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c RF Standard
Aug 17, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c Lp(a) Calibrators
Aug 17, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Xience Xpedition Everolimus Eluting Coronary Stent System
Aug 15, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
PERCLOSE PROGLIDE Suture-Mediated Closure System
Aug 15, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ARCHITECT SHBG Reagent Kit
Aug 14, 2023
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Lp(a) Control Kit
Aug 14, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT DHEA-S Controls
Aug 14, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT DHEA-S Reagent Kit
Aug 14, 2023
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT SCC Calibrators
Aug 14, 2023
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT DHEA-S Calibrators
Aug 14, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT SHBG Calibrators
Aug 11, 2023
Manufacturer
BIOKIT S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT SHBG Controls
Aug 11, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Alinity m SARS-CoV-2 AMP Kit
Aug 6, 2023
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
TECHNOPATH Multichem P
Aug 1, 2023
Manufacturer
TECHNO-PATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
TECHNOPATH Multichem WBT
Aug 1, 2023
Manufacturer
TECHNOPATH MANUFACTURING, LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
XIENCE Sierra Everolimus Eluting Coronary Stent System
Jul 25, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
TECHNOPATH Multichem A1c
Jul 17, 2023
Manufacturer
TECHNO-PATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
XIENCE ProA Everolimus Eluting Coronary Stent System
Jul 15, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ARCHITECT ARM Concentrated Wash Buffer
Jul 14, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ARCHITECT iGentamicin Calibrators
Jul 11, 2023
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Lipase Calibrator
Jul 11, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Methotrexate Calibrators
Jul 11, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Methotrexate Extended Range Controls
Jul 6, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT iGentamicin Reagent Kit
Jul 6, 2023
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Methotrexate Reagent Kit
Jul 4, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Direct LDL
Jun 30, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Methotrexate Controls
Jun 27, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Thyroglobulin Reagent Kit
Jun 26, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Abbott Gamma-Glutamyl Transferase
Jun 25, 2023
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
ARCHITECT Thyroglobulin Controls
Jun 23, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Thyroglobulin Calibrators
Jun 21, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT TSH Calibrators
Jun 21, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT TSH Reagent Kit
Jun 21, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HE4 Controls
Jun 17, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT HE4 Reagent Kit
Jun 16, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL-DYN Emerald 22 AL and accessories
Jun 16, 2023
Manufacturer
BIT ANALYTICAL INSTRUMENTS
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT T-Uptake Reagent Kit
Jun 13, 2023
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
Multiconstituent Calibrator
Jun 13, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Lipid Multiconstituent Calibrator Kit
Jun 13, 2023
Manufacturer
RANDOX LABORATORIES, LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT T-Uptake Calibrators
Jun 13, 2023
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
ARCHITECT Total β -hCG Reagent Kit
Jun 11, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT STAT High Sensitive Troponin-I Reagent Kit
Jun 9, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Intact PTH Reagent Kit
Jun 7, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Intact PTH Controls
Jun 6, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Intact PTH Calibrators
Jun 6, 2023
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT T-Uptake Controls
Jun 6, 2023
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
ARCHITECT C-Peptide Controls
Jun 5, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT C-Peptide Reagent Kit
May 30, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Ethanol Control Kit
May 30, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Progesterone Manual Diluent
May 28, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ARCHITECT i Theophylline Reagent Kit
May 23, 2023
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Ethanol Reagent Kit
May 23, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT i Theophylline Calibrators
May 23, 2023
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT C-Peptide Calibrators
May 22, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Trigger Solution
May 22, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY c Valproic Acid Reagent Kit
May 20, 2023
Manufacturer
MICROGENICS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Carbon Dioxide Calibrator
May 20, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Intact PTH Calibrators
May 20, 2023
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Ethanol Calibrator Kit
May 20, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HBsAg Controls
May 20, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Insulin Controls
May 20, 2023
Manufacturer
DENKA, CO. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Triclip G4 System
May 19, 2023
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ARCHITECT Intact PTH Reagent Kit
May 16, 2023
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Urine NGAL Controls
May 16, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY C Theophylline Reagent Kit
May 16, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Intact PTH Controls
May 16, 2023
Manufacturer
BIOKIT, S.A.,
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Insulin Reagent Kit
May 16, 2023
Manufacturer
DENKA, CO. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CMV IgM Reagent Kit
May 16, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTIC DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Concentrated Wash Buffer
May 16, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY c Phenobarbital Reagent Kit
May 10, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Creatine Kinase
May 7, 2023
Manufacturer
FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Glucose
May 5, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit
May 4, 2023
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT Direct Bilirubin
May 4, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT STAT CK-MB Calibrators
Apr 28, 2023
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
ABBOTT TDM Multiconstituent Calibrator
Apr 28, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Free T4 Controls
Apr 20, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Total T3 Manual Diluent
Apr 20, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Insulin Calibrators
Apr 20, 2023
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CMV IgM Controls
Apr 20, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Rubella IgM Reagent Kit
Apr 20, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CMV IgG Reagent Kit
Apr 20, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Prolactin Reagent Kit
Apr 20, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Free T4 Calibrators
Apr 20, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Insulin Reagent Kit
Apr 10, 2023
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Lactic Acid
Apr 5, 2023
Manufacturer
FISHER DIAGNOSTICS.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-Tg Calibrators
Apr 5, 2023
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
ALINITY i Anti-Tg Controls
Apr 5, 2023
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
ARCHITECT CMV IgG Avidity Reagent kit
Apr 5, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CMV IgG Controls
Apr 5, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CMV IgG Avidity Calibrator & Controls
Apr 5, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i ProGRP Calibrators
Apr 3, 2023
Manufacturer
DENKA CO.,LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Anti-Tg Reagent Kit
Apr 3, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT rHTLV-I/II Controls
Mar 31, 2023
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Aspartate Aminotransferase
Mar 30, 2023
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
ALINITY i UCH-L1 Calibrators
Mar 30, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Triglyceride
Mar 29, 2023
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
ABBOTT ICT Urine Calibrator
Mar 28, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT rHTLV-I/II Reagent
Mar 28, 2023
Manufacturer
ABBOTT GMBH
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ABBOTT Ultra HDL
Mar 28, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Urine/CSF Protein
Mar 27, 2023
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
GFAP Calibrators For Use With Alinity i
Mar 27, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Phosphorus
Mar 27, 2023
Manufacturer
FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
GFAP Reagent Kit For Use With Alinity i
Mar 22, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
UCH-L1 Reagent Kit For Use With Alinity i
Mar 22, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CMV IgM Calibrator
Mar 22, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT Alanine Aminotransferase For Use With Architect
Mar 22, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Carbon Dioxide For Use With Architect
Mar 22, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CMV IgG Calibrators
Mar 22, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT HBsAg Qualitative II Reagent Kit
Mar 18, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Rubella IgM Calibrator
Mar 15, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Rubella IgM Controls
Mar 15, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c Direct LDL Reagent Kit
Mar 13, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Lactic Acid2
Mar 3, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Lactic Acid2
Feb 27, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Calcium
Feb 27, 2023
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
ARCHITECT rHTLV-I/II Calibrator
Feb 20, 2023
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT STAT Myoglobin Calibrators
Feb 17, 2023
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
ALINITY i-series Probe Conditioning Solution
Feb 15, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY i Pepsinogen I Reagent Kit
Feb 15, 2023
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT i Carbamazepine Calibrators
Feb 13, 2023
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT i Carbamazepine Reagent Kit
Feb 13, 2023
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT LH Reagent Kit
Feb 10, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity h-series WBC Reagent
Feb 9, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Total β-hCG Controls
Feb 8, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT LH Calibrators
Feb 8, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Ferritin Reagent Kit
Feb 8, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT STAT Myoglobin Reagent Kit
Feb 8, 2023
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
ABBOTT Lactate Dehydrogenase
Feb 8, 2023
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
ABBOTT ICT Serum Calibrator
Feb 8, 2023
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
ARCHITECT TSH Controls
Feb 6, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Ferritin Calibrators
Feb 6, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-Tg Calibrators
Feb 2, 2023
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
ARCHITECT Ferritin Controls
Feb 2, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Folate Reagent Kit
Feb 2, 2023
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Cortisol Reagent Kit
Feb 2, 2023
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
ARCHITECT STAT Myoglobin Controls
Feb 2, 2023
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT STAT CK-MB Controls
Feb 2, 2023
Manufacturer
MICROGENICS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity c-series Maintenance Solution
Jan 24, 2023
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
TECHNOPATH Multichem U
Dec 30, 2022
Manufacturer
TECHNOPATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Pepsinogen II Reagent Kit
Dec 26, 2022
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
TECHNOPATH Multichem IA Plus
Dec 26, 2022
Manufacturer
TECHNOPATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CEA Calibrators
Dec 26, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
TECHNOPATH Multichem S Plus (Unassayed)
Dec 20, 2022
Manufacturer
TECHNOPATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CEA Reagent Kit
Dec 19, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Free PSA Reagent Kit
Dec 19, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Total PSA Reagent Kit
Dec 19, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT CEA Controls
Dec 19, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
TECHNOPATH Multichem S Plus (Assayed)
Dec 19, 2022
Manufacturer
TECHNOPATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Total PSA Controls
Dec 19, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Total PSA Calibrators
Dec 19, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Methotrexate Extended Range Controls
Dec 9, 2022
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Pepsinogen I Controls
Dec 9, 2022
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Pepsinogen II Controls
Dec 8, 2022
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Pepsinogen I Calibrators
Dec 8, 2022
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
HI-TORQUE PILOT 50 Guide Wire With Hydrophylic Coating
Dec 8, 2022
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Pepsinogen II Calibrators
Dec 8, 2022
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Retic Plus Control
Dec 8, 2022
Manufacturer
LINE.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
HI-TORQUE VERSATURN Guide Wire
Dec 6, 2022
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
Alinity c Total Bile Acids Calibrator Kit
Dec 5, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CYFRA 21-1 Reagent Kit
Nov 28, 2022
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c CK-MB Reagent Kit
Nov 24, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c CRP Vario Wide Range Calibrator Kit
Nov 24, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Ceruloplasmin
Nov 24, 2022
Manufacturer
SENTINEL CH, SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c UIBC Reagent Kit
Nov 21, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c UIBC Calibrator Kit
Nov 21, 2022
Manufacturer
SENTINEL CH. S.P.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c CK-MB Calibrator Kit
Nov 21, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c CK-MB Control Kit
Nov 21, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Iron Reagent Kit
Nov 21, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Immuno Control 2 Kit
Nov 17, 2022
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT i2000 SR and Accessories
Nov 17, 2022
Manufacturer
FLEXTRONICS MANUFACTURING (SINGAPORE) PTE., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Cholinesterase Reagent Kit
Nov 17, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY c Clinical Chemistry Calibrator Kit
Nov 16, 2022
Manufacturer
SENTINEL CH., SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Plasmaproteins Cal 3x Kit
Nov 16, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Ceruloplasmin Reagent Kit
Nov 16, 2022
Manufacturer
SENTINEL CH S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Clinical Chemistry Control 2 Kit
Nov 16, 2022
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Cystatin C Calibrator
Nov 11, 2022
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Creatinine (Enzymatic) Reagent Kit
Nov 10, 2022
Manufacturer
SENTINEL CH. S.P.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Immuno Control 2
Nov 10, 2022
Manufacturer
SENTINEL CH, SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Immuno Control Set
Nov 9, 2022
Manufacturer
SENTINEL CH, SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c CRP Vario High Sensitivity Calibrator Kit
Nov 9, 2022
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c CRP Vario Reagent Kit
Nov 9, 2022
Manufacturer
SENTINEL CH. S.P.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-Tg Controls
Nov 9, 2022
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
ALINITY c Clinical Chemistry Control 1 Kit
Nov 9, 2022
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Immuno Control Set
Nov 9, 2022
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Abbott Alinity m HIV-1 AMP Kit
Nov 9, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ABBOTT Clin Chem Cal
Nov 8, 2022
Manufacturer
SENTINEL CH SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Immuno Control 1 Kit
Nov 8, 2022
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Immuno Control 1
Nov 8, 2022
Manufacturer
SENTINEL CH, SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Plasmaproteins Cal 3x
Nov 8, 2022
Manufacturer
SENTINEL CH, SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT c8000 Processing Module and Accessories
Nov 8, 2022
Manufacturer
CANON MEDICAL SYSTEMS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i ProGRP Reagent Kit
Nov 7, 2022
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i SCC Reagent Kit
Nov 7, 2022
Manufacturer
DENKA SEIKEN CO.,LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT CRP Calibrator HS
Nov 4, 2022
Manufacturer
SENTINEL CH, SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-TPO Calibrators
Nov 4, 2022
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
ABBOTT Cystatin C
Nov 4, 2022
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i SHBG Controls
Nov 3, 2022
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i SHBG Calibrators
Nov 3, 2022
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i PIVKA-II Reagent Kit
Nov 3, 2022
Manufacturer
DENKA SEIKEN CO.,LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i B.R.A.H.M.S PCT Reagent Kit
Oct 31, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i C-Peptide Reagent Kit
Oct 27, 2022
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i SHBG Reagent Kit
Oct 27, 2022
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i DHEA-S Reagent Kit
Oct 27, 2022
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Homocysteine Calibrators
Oct 27, 2022
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : B
HI-TORQUE Proceed 170T Angled Guide Wire with Hydrophilic Coating
Oct 26, 2022
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
HI-TORQUE Proceed 220T Angled Guide Wire with Hydrophilic Coating
Oct 26, 2022
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i C-Peptide Controls
Oct 24, 2022
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Homocysteine Reagent Kit
Oct 24, 2022
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i C-Peptide Calibrators
Oct 24, 2022
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
AlinIQ AMS
Oct 24, 2022
Manufacturer
ABBOTT S.R.L.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY i ProGRP Calibrators
Oct 21, 2022
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Prealbumin Calibrator Kit
Oct 20, 2022
Manufacturer
NITTOBO MEDICAL CO., LTD. MEDICAL DEVELOPMENT CENTER.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-TPO Reagent Kit
Oct 19, 2022
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
ARCHITECT Total β-hCG Calibrators
Oct 19, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i ProGRP Controls
Oct 18, 2022
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Toxo IgG Reagent Kit
Oct 18, 2022
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Homocysteine Controls
Oct 18, 2022
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-CCP Controls
Oct 18, 2022
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Anti-CCP Calibrators
Oct 18, 2022
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Anti-CCP Reagent Kit
Oct 18, 2022
Manufacturer
AXIS-SHIELD DIAGNOSTICS LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT STAT CK-MB Reagent Kit
Oct 14, 2022
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
Alinity i NSE Calibrators
Oct 14, 2022
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Pancreatic Amylase Reagent Kit
Oct 14, 2022
Manufacturer
SENTINEL CH. S.P.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT CRP Vario
Oct 7, 2022
Manufacturer
SENTINEL CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
SENTINEL Cystatin C Control Set
Oct 7, 2022
Manufacturer
SENTINEL CH SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Alinity m SARS-CoV-2 CTRL Kit
Oct 5, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Creatinine (Enzymatic)
Sep 29, 2022
Manufacturer
SENTINEL CH. S.PA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Folate Manual Diluent
Sep 28, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Emerald Diluent
Sep 28, 2022
Manufacturer
CLINICAL DIAGNOSTIC SOLUTIONS
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Rubella IgM Controls
Sep 26, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL-DYN Emerald CN-Free Lyse
Sep 21, 2022
Manufacturer
CLINICAL DIAGNOSTIC SOLUTIONS
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT iPhenytoin Reagent kit
Sep 16, 2022
Manufacturer
DENKA, CO. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Cyfra 21-1 Controls
Sep 12, 2022
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Rubella IgM Controls
Sep 12, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Cyfra 21-1 Calibrators
Sep 8, 2022
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Cyfra 21-1 Reagent Kit
Sep 8, 2022
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Toxo IgG Controls
Sep 7, 2022
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL-DYN Sapphire System WBC Reagent-Part A
Sep 6, 2022
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
HI-TORQUE WHISPER Guide Wire
Sep 1, 2022
Manufacturer
ABBOTT VASCULAR.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL-DYN Diluent/Sheath (CELL-DYN Sapphire and CELL-DYN Ruby Systems)
Sep 1, 2022
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
ARCHITECT Toxo IgG Avidity Reagent Kit
Sep 1, 2022
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Toxo IgG Calibrators
Aug 31, 2022
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT iPhenytoin Calibrators
Aug 30, 2022
Manufacturer
DENKA, CO. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT iValproic Acid Reagent Kit
Aug 30, 2022
Manufacturer
DENKA, CO. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT iValproic Acid Calibrators
Aug 30, 2022
Manufacturer
DENKA, CO. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HE4 Calibrators
Aug 29, 2022
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL-DYN Sapphire System WBC Reagent-Part B
Aug 29, 2022
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
ALINITY i Progesterone Manual Diluent
Aug 29, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 1
Risk Class
Kelas Resiko : A
CELL-DYN Emerald 22 Lyse
Aug 26, 2022
Manufacturer
BIT GROUP FRANCE
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Alinity m HIV-1 CAL Kit
Aug 25, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Toxo IgG Avidity Calibrator & Controls
Aug 24, 2022
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL-DYN Ruby Systems WBC Lyse
Aug 23, 2022
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
ALINITY i LH Calibrators
Aug 23, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Ruby Systems CN-Free HGB/NOC Lyse
Aug 23, 2022
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
CELL-DYN Sapphire Systems CN-FREE HGB Reagent
Aug 23, 2022
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
ALINITY i LH Reagent Kit
Aug 23, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Iron2
Aug 21, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Alkaline Phosphatase2
Aug 21, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Iron2
Aug 21, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT iPhenobarbital Calibrators
Aug 21, 2022
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT B12 Reagent Kit
Aug 21, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Alinity m HR HPV CTRL Kit
Aug 21, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Hemoglobin A1c Calibrators
Aug 18, 2022
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i FSH Reagent Kit
Aug 16, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT ALINITY m HBV CTRL Kit
Aug 16, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Creatinine2
Aug 15, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Aspartate Aminotransferase2
Aug 15, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i TRAb Calibrators
Aug 12, 2022
Manufacturer
DENKA, CO. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Alkaline Phosphatase2
Aug 12, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT ALINITY m HCV CTRL Kit
Aug 12, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Abbott Alinity m HBV CAL Kit
Aug 12, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Abbott Alinity m HCV CAL Kit
Aug 12, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i TRAb Controls
Aug 12, 2022
Manufacturer
DENKA, CO. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-CCP Reagent Kit
Aug 12, 2022
Manufacturer
AXIS SHIELD DIAGNOSTICS LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL-DYN Emerald Cleaner
Aug 12, 2022
Manufacturer
CLINICAL DIAGNOSTIC SOLUTIONS
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY h-series Diluent
Aug 12, 2022
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
ALINITY c Total Bilirubin2
Aug 12, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i TRAb Reagent Kit
Aug 12, 2022
Manufacturer
DENKA, CO. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Total Bilirubin2
Aug 12, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti CCP Calibrators
Aug 9, 2022
Manufacturer
AXIS SHIELD DIAGNOSTICS LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Anti CCP Controls
Aug 9, 2022
Manufacturer
AXIS SHIELD DIAGNOSTICS LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Hemoglobin A1c
Jul 27, 2022
Manufacturer
SEKISUI DIAGNOSTICS P.E.I INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Alanine Aminotransferase2
Jul 25, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Total Bilirubin Reagent Kit
Jul 22, 2022
Manufacturer
SEKISUI DIAGNOSTICS P.E.I., INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Aspartate Aminotransferase2
Jul 22, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Hemoglobin A1c Controls
Jul 22, 2022
Manufacturer
SEKISUI DIAGNOSTICS P.E.I INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i FSH Controls
Jul 22, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i FSH Calibrators
Jul 22, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HCV Ag Controls
Jul 21, 2022
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY m multi-Collect Specimen Collection Kit
Jul 18, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ARCHITECT Gamma-Glutamyl Transferase2
Jul 17, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Abbott Alinity m Lysis solution
Jul 14, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBC II Controls
Jul 14, 2022
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Abbott Alinity m Diluent Solution
Jul 14, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Alinity m Sample Prep Kit 1
Jul 14, 2022
Manufacturer
ABBOTT MOLECULAR, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBC II Calibrator
Jul 13, 2022
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Digoxin Reagent Kit
Jul 13, 2022
Manufacturer
MICROGENICS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Phenytoin Reagent Kit
Jul 13, 2022
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Gentamicin Reagent Kit
Jul 13, 2022
Manufacturer
MICROGENICS CORPORATION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBc II Reagent Kit
Jul 7, 2022
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HCV Ag Calibrators
Jul 6, 2022
Manufacturer
DENKA CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Toxo IgM Calibrator
Jul 1, 2022
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Toxo IgM Reagent Kit
Jul 1, 2022
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT HSV-2 IgG Reagent Kit
Jul 1, 2022
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT HSV-1 IgG Controls
Jun 28, 2022
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Toxo IgM Controls
Jun 22, 2022
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
TECHNOPATH Multichem IA Plus
Apr 28, 2022
Manufacturer
TECHNOPATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
TECHNOPATH Multichem S Plus (Assayed)
Apr 25, 2022
Manufacturer
TECHNOPATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
TECHNOPATH Multichem S Plus (Unassayed)
Apr 25, 2022
Manufacturer
TECHNOPATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
TECHNOPATH Multichem U
Apr 25, 2022
Manufacturer
TECHNOPATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
TECHNOPATH Multichem P
Apr 25, 2022
Manufacturer
TECHNOPATH MANUFACTURING LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY hq Analyzer and Accessories
Apr 18, 2022
Manufacturer
SANMINA-SCI SYSTEMS.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Cholinesterase
Apr 4, 2022
Manufacturer
SENTINEL CH., SPA.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY i Cortisol Calibrators
Apr 4, 2022
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Alanine Aminotransferase2
Mar 31, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY h-series HGB Reagent
Mar 24, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Total PSA Calibrators
Mar 24, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Total PSA Controls
Mar 24, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Total PSA Reagent Kit
Mar 22, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Free PSA Reagent Kit
Mar 16, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Free PSA Controls
Mar 16, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Free PSA Calibrators
Mar 14, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Anti-HCV Controls
Mar 10, 2022
Manufacturer
Abbott GmbH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HCV Calibrator
Mar 9, 2022
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Triglyceride2
Feb 22, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Triglyceride2
Feb 11, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT UIBC
Feb 8, 2022
Manufacturer
SENTINEL CH, S.P.A..
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Total T3 Reagent Kit
Feb 3, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CRP Calibrator Set
Jan 31, 2022
Manufacturer
SENTINEL CH., SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT CK-MB
Jan 31, 2022
Manufacturer
SENTINEL CH SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Free T3 Controls
Jan 30, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Free T3 Reagent Kit
Jan 28, 2022
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Clin Chem Control 1
Jan 25, 2022
Manufacturer
Sentinel CH. SpA
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Clin Chem Control 2
Jan 20, 2022
Manufacturer
SENTINEL CH., SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i T-Uptake Controls
Jan 15, 2022
Manufacturer
FISHER DIAGNOSTICS IS PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Emerald Diluent
Dec 24, 2021
Manufacturer
CLINICAL DIAGNOSTIC SOLUTION INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Microalbumin Reagent Kit
Dec 17, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HBs Reagent Kit
Dec 15, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ARCHITECT Anti-HBe Calibrator
Dec 10, 2021
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBe Reagent Kit
Dec 9, 2021
Manufacturer
ABBOTT GMBH
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY c Ammonia Ultra Reagent Kit
Dec 8, 2021
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBs Reagent Kit
Dec 7, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
CELL DYN Sapphire and Accessories
Dec 7, 2021
Manufacturer
FLEXTRONICS MANUFACTURING PTE. LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Manual Diluent
Dec 6, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Quantitative Reagent Kit
Nov 27, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i CMV IgG Avidity Reagent Kit
Nov 23, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT CN-Free HGB/NOC Lyse (Cell-Dyn Ruby, Cell DYn 3200 System)
Nov 22, 2021
Manufacturer
ABBOTT LABORATORIES.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBe Controls
Nov 22, 2021
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Emerald CN-Free Lyse
Nov 22, 2021
Manufacturer
ABBOTT LABORATORIES.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HBeAg Calibrators
Nov 22, 2021
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit
Nov 21, 2021
Manufacturer
AXIS-SHIELD DIAGNOSTICS LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Ammonia Controls
Nov 20, 2021
Manufacturer
SENTINEL CH. S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Emerald Cleaner
Nov 20, 2021
Manufacturer
ABBOTT LABORATORIES.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
CELL-DYN Reticulocyte Reagent
Nov 18, 2021
Manufacturer
ABBOTT LABORATORIES.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Albumin BCP Reagent Kit
Nov 15, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Microalbumin Controls
Nov 15, 2021
Manufacturer
FISHER DIAGNOSTICS IS PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBs Reagent Kit
Nov 15, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY c Albumin BCG Reagent Kit
Nov 15, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Cholesterol Reagent Kit
Nov 15, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Magnesium Reagent Kit
Nov 15, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Microalbumin Calibrators
Nov 15, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBs Calibrators
Nov 11, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Creatinine Reagent Kit
Nov 11, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HBs Controls
Nov 11, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Triglyceride Reagent Kit
Nov 9, 2021
Manufacturer
FISHER DIAGNOSTICS IS PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HAVAb-IgG Calibrator
Nov 8, 2021
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Microalbumin Controls
Nov 8, 2021
Manufacturer
FISHER DIAGNOSTICS IS PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Lactate Dehydrogenase Reagent Kit
Nov 8, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i T-Uptake Calibrators
Nov 8, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Qualitative II Confirmatory Reagent Kit
Nov 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ARCHITECT HAVAb-IgG Controls
Nov 4, 2021
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALKALINE Phosphatase
Nov 4, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CMV IgG Avidity Controls
Nov 2, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c Alkaline Phosphatase Reagent Kit
Nov 1, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HBeAg Controls
Oct 29, 2021
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Cyclosporine Whole Blood Precipitation Reagent Kit
Oct 27, 2021
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
SUPERA Peripheral Stent System
Oct 26, 2021
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY c Carbon Dioxide Reagent Kit
Oct 25, 2021
Manufacturer
SEKISUI DIAGNOSTICS P.E.I INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Multi-Assay Manual Diluent
Oct 25, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i 25-OH Vitamin D Controls
Oct 22, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Transferrin Reagent Kit
Oct 22, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HBs Reagent Kit
Oct 18, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i HBsAg Reagent Kit
Oct 13, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Confirmatory V.1 Reagent Kit
Oct 13, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Confirmatory V.1 Controls
Sep 25, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Uric Acid Reagent Kit
Sep 21, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Gamma-Glutamyl Transferase Reagent Kit
Sep 21, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c-series Acid Probe Wash
Sep 21, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY i Free T4 Controls
Sep 21, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Total T4 Controls
Sep 19, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity i Estradiol Manual Diluent Kit
Sep 19, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i TSH Controls
Sep 18, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Free T3 Controls
Sep 18, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Total T3 Manual Diluent
Sep 18, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY i CMV IgM Calibrator
Sep 17, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i HBsAg Confirmatory V.1 Calibrators
Sep 16, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i AFP Controls
Sep 16, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Qualitative II Calibrators
Sep 16, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Qualitative II Controls
Sep 11, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HAVAb-IgM Controls
Sep 11, 2021
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Calibrators
Sep 10, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT HAVAb-IgM Calibrator
Sep 10, 2021
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Controls
Sep 10, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Ferritin Controls
Sep 10, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HBs Calibrators
Sep 6, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HBs Controls
Sep 6, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT B.R.A.H.M.S PCT Controls
Sep 6, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Qualitative II Reagent Kit
Sep 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i-series Concentrated Wash Buffer
Sep 3, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISON.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY i Total β-hCG Controls
Sep 3, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Cortisol Reagent Kit
Sep 2, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Total T3 Calibrators
Sep 2, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i SARS-CoV-2 IgG II Quant Control Kit
Aug 31, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT B.R.A.H.M.S PCT Calibrators
Aug 31, 2021
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
ALINITY i AFP Calibrators
Aug 31, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i AFP Reagent Kit
Aug 30, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i 25-OH Vitamin D Calibrators
Aug 27, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Rubella IgM Calibrator
Aug 27, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Rubella IgM Reagent Kit
Aug 25, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Processing Module
Aug 25, 2021
Manufacturer
SANMINA-SCI SYSTEMS SINGAPORE PTE. LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CEA Reagent Kit
Aug 24, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY c IgE Standard
Aug 21, 2021
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY in CMV IgM Reagent Kit
Aug 21, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CEA Calibrators
Aug 19, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CEA Controls
Aug 18, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i SARS-CoV-2 IgG II Quant Reagent Kit
Aug 16, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Rubella IgG Calibrators
Aug 16, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Free T3 Reagent Kit
Aug 14, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CMV IgM Controls
Aug 12, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CMV IgG Calibrators
Aug 12, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i CMV IgG Controls
Aug 12, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Rubella IgG Controls
Aug 6, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Rubella IgM Controls
Aug 6, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Estradiol Reagent Kit
Aug 6, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Free T3 Calibrators
Aug 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Estradiol Calibrators
Aug 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i CMV IgG Reagent Kit
Aug 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ALINITY i Total T3 Reagent Kit
Aug 3, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Estradiol Controls
Aug 3, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT c4000 Processing Module and Accessories
Jul 30, 2021
Manufacturer
CANON MEDICAL SYSTEMS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Total T4 Reagent Kit
Jul 26, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Ferritin Reagent Kit
Jul 23, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISON.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i 25-OH Vitamin D Reagent Kit
Jul 23, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Free T4 Reagent Kit
Jul 23, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Free T4 Calibrators
Jul 23, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Ferritin Calibrators
Jul 23, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Prolactin Reagent Kit
Jul 21, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Total T4 Calibrators
Jul 21, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Total B-hCG Calibrators
Jul 21, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT FSH Calibrators
Jul 21, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c-series Detergent B
Jul 18, 2021
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ARCHITECT FSH Reagent Kit
Jul 15, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Apolipoprotein B
Jul 7, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Aspartate Aminotransferase Reagent Kit
Jul 6, 2021
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
ABBOTT ICT Sample Diluent
Jul 6, 2021
Manufacturer
ABBOTT LABORATORIES.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Amylase Reagent Kit
Jul 2, 2021
Manufacturer
SEKISUI DIAGNOSTICS P.E.I INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c-series Alkaline Wash
Jun 30, 2021
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
ALINITY c-series Detergent A
Jun 30, 2021
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY c-series Acid Wash
Jun 27, 2021
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
ALINITY c Total Protein Reagent Kit
Jun 21, 2021
Manufacturer
FISHER DIAGNOSTICS. A PART OF THERMO FISHER SCIENTIFIC, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT i1000 SR Integrated Module and Accessories
Jun 17, 2021
Manufacturer
FLEXTRONICS MANUFACTURING PTE LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT c4000 Processing Module and Accessories (Integrated)
Jun 17, 2021
Manufacturer
CANON MEDICAL SYSTEMS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti HCV Reagent Kit
Jun 11, 2021
Manufacturer
ABBOTT GMBH & CO. Medical history
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HCV Calibrator
Jun 10, 2021
Manufacturer
ABBOTT GMBH & CO. KG.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HCV Controls
Jun 10, 2021
Manufacturer
ABBOTT GMBH & CO. KG.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Microalbumin Controls
May 31, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Lipase
May 31, 2021
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Microalbumin Calibrators
May 31, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Microalbumin
May 28, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Microalbumin Calibrators
May 21, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Processing Module and Accessories
May 11, 2021
Manufacturer
SANMINA-SCI SYSTEMS, PTE., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Microalbumin Controls
May 6, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Apolipoprotein A1
May 6, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i STAT High Sensitive Troponin-I Reagent Kit
May 6, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ACCELERATOR a3600 and Accessories
May 5, 2021
Manufacturer
INPECO S.P.A.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY c Immunoglobulin G
May 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Apolipoprotein A1
May 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Prealbumin
May 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL DYN 26 Plus Control
May 5, 2021
Manufacturer
LINE.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Tacrolimus Whole Blood Precipitation Reagent
May 5, 2021
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT i1000 SR Processing Module and Accessories
May 5, 2021
Manufacturer
FLEXTRONICS MANUFACTURING PTE LTD
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Apolipoprotein B
May 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Sirolimus Calibrators
May 3, 2021
Manufacturer
FUJIREBIO DIAGNOSTICS INC .
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Prealbumin
May 3, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i SARS-CoV-2 IgM Control Kit
May 3, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i SARS-CoV-2 IgG Reagent Kit
May 3, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Haptoglobin
May 1, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Complement C4
May 1, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i SARS-CoV-2 IgM Calibrator Kit
Apr 26, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Sirolimus Whole Blood Precipitation Reag
Apr 21, 2021
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT Sirolimus Reagent Kit
Apr 21, 2021
Manufacturer
FUJIREBIO DIAGNOSTICS INC .
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT Rheumatoid Factor
Apr 19, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : C
CELL DYN Emerald
Apr 19, 2021
Manufacturer
BIT ANALYTICAL INSTRUMENTS GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Immunoglobulin A
Apr 19, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Uric Acid2
Apr 19, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Immunoglobulin M
Apr 19, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
SENTINEL Pancreatic Amylase
Apr 16, 2021
Manufacturer
SENTINEL CH, S.P.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
SENTINEL Iron
Apr 16, 2021
Manufacturer
Sentinel CH. SPA.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Complement C3
Apr 16, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ICT Module
Apr 13, 2021
Manufacturer
CANON MEDICAL SYSTEMS CORPORATION.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
Alinity c Total Protein2
Apr 13, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN 18 Plus Control
Apr 9, 2021
Manufacturer
LINE.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Cholesterol2
Apr 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Albumin BCG2
Apr 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY Albumin BCP2
Apr 5, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT AFP Reagent Kit
Mar 25, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT AFP Controls
Mar 8, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY Pre-Trigger Solution
Mar 8, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY Trigger Solution
Mar 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ABBOTT SARS-CoV-2 IgG Control Kit
Mar 1, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Next Confirmatory Manual Diluent
Feb 19, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Immunoglobulin M
Jan 17, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Immunoglobulin G
Jan 15, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Uric Acid2
Jan 11, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Creatinine2
Jan 11, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Complement C3
Jan 11, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Transferrin
Jan 8, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Transferrin
Jan 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Complement C4
Jan 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Immunoglobulin A
Jan 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Magnesium
Jan 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Albumin BCP2
Jan 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Next Qualitative Reagent Kit
Jan 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ABBOTT Haptoglobin
Jan 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c Magnesium
Jan 4, 2021
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HCV Reagent Kit
Dec 22, 2020
Manufacturer
ABBOTT GMBH.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY i Tacrolimus Calibrators
Dec 21, 2020
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Sirolimus Calibrators
Dec 21, 2020
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Next Qualitative Calibrators
Dec 21, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Next Confirmatory Reagent Kit
Dec 20, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ABBOTT Total Protein2
Dec 18, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Urea Nitrogen2
Dec 16, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Thyroglobulin Controls
Dec 16, 2020
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Thyroglobulin Calibrators
Dec 16, 2020
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Thyroglobulin Reagent Kit
Dec 15, 2020
Manufacturer
FUJIREBIO DIAGNOSTICS, INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i HBsAg Next Qualitative Controls
Dec 15, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Sirolimus Whole Blood Precipitation Reagent
Dec 10, 2020
Manufacturer
FUJIREBIO DIAGNOSTICS, INC
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT Cholesterol2
Dec 1, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
Alinity i Anti-HCV Calibrator
Dec 1, 2020
Manufacturer
ABBOTT GMBH
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Anti-HCV Controls
Nov 25, 2020
Manufacturer
ABBOTT GMBH.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Progesterone Reagent Kit
Nov 22, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISON.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Total T4 Calibrators
Nov 22, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Emerald 22 Easy Cleaner
Nov 12, 2020
Manufacturer
AVANTOR PERFORMANCE MATERIALS S.A.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
CELL-DYN Immuno PLT (CD61)
Nov 6, 2020
Manufacturer
BD BIOSCIENCES.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
CELL-DYN Immuno T-Cell (CD3/4/8) Reagents
Oct 27, 2020
Manufacturer
BD BIOSCIENCES.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT 20/30 Priority Pack Accessory Kit with .115" RHV
Aug 25, 2020
Manufacturer
AVAILMED S.A. DE C.V.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT 20/30 Priority Pack Accessory Kit with .096
Aug 16, 2020
Manufacturer
AVAILMED S.A DE C.V.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
HI-TORQUE Balance Middleweight Elite Guide Wire
Aug 14, 2020
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT 20/30 INDEFLATOR Inflation Device
Aug 14, 2020
Manufacturer
AVAILMED S.A DE C.V.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
MINI TREK RX Coronary Dilatation Catheter
Aug 12, 2020
Manufacturer
ABBOTT VACULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
NC TREK RX Coronary Dilatation Catheter
Aug 10, 2020
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
XIENCE PRIME SV Everolimus Eluting Coronary Stent System
Jul 24, 2020
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
Alinity s HBsAg Reagent Kit
Jun 10, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY s HBsAg Confirmatory Reagent Kit
Jun 9, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ACCELERATOR p540 Aliquoter Module and Accessories
May 8, 2020
Manufacturer
A&T CORPORATION.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ABBOTT Immunoglobulin G
Apr 24, 2020
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
ABBOTT Immunoglobulin M
Apr 17, 2020
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
Alinity s HBsAg Calibrator Kit
Apr 8, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Immunoglobulin A
Apr 8, 2020
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
RX HERCULINK ELITE Peripheral Stent System
Apr 8, 2020
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ALINITY s HBsAg Assay Control Kit
Apr 7, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY s HBsAg Release Control Kit
Apr 7, 2020
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Apolipoprotein B
Apr 7, 2020
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
ABBOTT Complement C3
Apr 7, 2020
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
ABBOTT Apolipoprotein A1
Apr 3, 2020
Manufacturer
FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
HI-TORQUE Connect Flex Guide Wire
Apr 2, 2020
Manufacturer
LAKE REGION MEDICAL LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : C
HI-TORQUE Supra Core 35 Guide Wire
Apr 2, 2020
Manufacturer
ABBOTT VASCULAR.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ABBOTT Complement C4
Apr 2, 2020
Manufacturer
FISHER DIAGNOSTICS, A DIVISION FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC
Class
Kelas : 2
Risk Class
Kelas Resiko : B
OMNILINK ELITE Peripheral Stent System
Apr 1, 2020
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
HI-TORQUE Connect 250T Guide Wire
Mar 22, 2020
Manufacturer
LAKE REGION MEDICAL LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : C
Prealbumin
Mar 18, 2020
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
HI-TORQUE Connect Guide Wire
Mar 6, 2020
Manufacturer
LAKE REGION MEDICAL LIMITED
Class
Kelas : 2
Risk Class
Kelas Resiko : C
20/30 PRIORITY PACK with COPILOT Bleedback Control Valve
Jan 22, 2020
Manufacturer
AVAILMED S.A. DE C.V.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
XIENCE PRIME LL Everolimus Eluting Coronary Stent System
Dec 12, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
XIENCE PRIME Everolimus Eluting Coronary Stent System
Dec 12, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
XIENCE PRO X Everolimus Eluting Coronary Stent System
Dec 12, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
XIENCE PRIME BTK EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Dec 10, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
AMOUNT Myoglobin
Nov 29, 2019
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
MULTI-LINK 8 SV Coronary Stent System
Nov 25, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
MULTI-LINK 8 LL Coronary Stent System
Nov 25, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
MULTI-LINK 8 Coronary Stent System
Nov 19, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
STARCLOSE SE Vascular Closure System
Nov 19, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
XIENCE Xpedition SV Everolimus Eluting Coronary Stent System
Nov 19, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
XIENCE Xpedition LL Everolimus Coronary Stent System
Nov 19, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 3
Risk Class
Kelas Resiko : D
HI-TORQUE Progress 40 Guide Wire
Nov 12, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
HI-TORQUE Progress 80 Guide Wire
Nov 12, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
HI-TORQUE Extra S'port Guide Wire
Nov 5, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
ARCHITECT ProGRP Calibrators
Oct 28, 2019
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Pro GRP Controls
Oct 17, 2019
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
MINI TREK II OTW Coronary Dilatation Catheter
Oct 17, 2019
Manufacturer
ABBOTT VASCULAR
Class
Kelas : 2
Risk Class
Kelas Resiko : C
COPILOT BleedBack Control Valve
Oct 9, 2019
Manufacturer
AVAILMED S.A DE C.V.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Insulin Reagent
Jul 29, 2019
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Insulin Controls
Jul 29, 2019
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Insulin Calibrators
Jul 29, 2019
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Ultra HDL
Jul 5, 2019
Manufacturer
ABBOTT LABORATORIES
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c A-1-AGP Reagent Kit
Jul 3, 2019
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c β2-Microglobulin Standard
Jun 14, 2019
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c β2-Microglobulin Reagent Kit
Jun 13, 2019
Manufacturer
BIOKIT, S.A
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c A1-Antitrypsin Reagent Kit
Jun 13, 2019
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Pre-Trigger Solution
May 22, 2019
Manufacturer
ABBOTT IRELAND DIAGNOSTICS DIVISION.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Anti-HCV Reagent Kit
Mar 29, 2019
Manufacturer
ABBOTT GMBH & CO. KG.
Class
Kelas : 3
Risk Class
Kelas Resiko : D
ARCHITECT BNP Controls
Mar 28, 2019
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT SHBG Calibrators
Mar 11, 2019
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ABBOTT Triglyceride
Mar 11, 2019
Manufacturer
ABBOTT LABORATORIES
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Insulin Calibrators
Mar 11, 2019
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT SHBG Controls
Feb 26, 2019
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT SHBG Reagent Kit
Feb 26, 2019
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
BIOKIT Lp (a) Control
Feb 18, 2019
Manufacturer
BIOKIT, S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY c-series Detergent B
Feb 18, 2019
Manufacturer
SEKISUI DIAGNOSTICS P.E.I. INC.
Class
Kelas : 1
Risk Class
Kelas Resiko : A
ALINITY i Insulin Controls
Feb 15, 2019
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ALINITY i Insulin Reagent Kit
Feb 15, 2019
Manufacturer
DENKA SEIKEN CO., LTD.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
QUANTIA Ferritin / Myoglobin / IgE Control
Feb 15, 2019
Manufacturer
BIOKIT S.A.
Class
Kelas : 2
Risk Class
Kelas Resiko : B
ARCHITECT Cyclosporin Reagent Kit
Feb 15, 2019
Manufacturer
FUJIREBIO DIAGNOSTICS INC.
Class
Kelas : 2
Risk Class
Kelas Resiko : C
About this profile

Data sourced from Ministry of Health, Indonesia.

Last updated: September 2026