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ABBOTT PRODUCTS INDONESIA

Authorized Representative in Indonesia

Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA
199 Products Represented
46 Manufacturers
Total Products
199
Manufacturers
46
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
21 products
10.6%
Kelas Resiko : B
117 products
58.8%
Kelas Resiko : C
54 products
27.1%
Kelas Resiko : D
7 products
3.5%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (199)
Complete portfolio registered with BPOM

ARCHITECT Estradiol Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

ARMADA 35 PTA Catheter

Manufacturer:

ABBOTT VASCULAR COSTA RICA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2024

ARCHITECT PIVKA-II Reagent Kit

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2024

ARCHITECT PIVKA-II Controls

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2024

ALINITY i PIVKA-II Controls

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2024

ALINITY i PIVKA-II Calibrators

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2024

XIENCE Xpedition 48 Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 3, 2024

ALINITY c Calcium2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 11, 2024

HI-TORQUE Command 18 LT Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 7, 2024

ARCHITECT BNP Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 2, 2024

ARCHITECT iValproic Acid Calibrators

Manufacturer:

DENKA CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 2, 2024

ALINITY i BNP Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

ARCHITECT iValproic Acid Reagent Kit

Manufacturer:

DENKA CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

ARCHITECT SCC Reagent Kit

Manufacturer:

DENKA SEIKEN CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

ARCHITECT PIVKA-II Controls

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

ARCHITECT PIVKA II-Reagent Kit

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

ARCHITECT PIVKA-II Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

ARCHITECT STAT High Sensitive Troponin-I Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

ARCHITECT GFAP Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2024

ARCHITECT UCH-L1 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

ARCHITECT GFAP Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

ARCHITECT UCH-L1 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2024

ARCHITECT Tacrolimus Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 8, 2024

ARCHITECT GFAP Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

ARCHITECT UCH-L1 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

ARCHITECT Anti-TPO Calibrators

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2024

ALINITY i SCC Controls

Manufacturer:

DENKA SEIKEN CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2024

ARCHITECT SCC Controls

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

ARCHITECT Anti-TPO Controls

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

ALINITY i Tacrolimus Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

ARCHITECT SCC Calibrators

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

ALINITY i Anti-HBe Reagent Kit

Manufacturer:

ABBOTT GMBH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 9, 2024

ALINITY i HBeAg Reagent Kit

Manufacturer:

ABBOTT GmbH

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 9, 2024

ARCHITECT STAT CK-MB Reagent Kit

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2024

ARCHITECT HBsAg Qualitative II Confirmatory Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

TREK RX Coronary Dilatation Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 24, 2023

HI-TORQUE WHISPER MS Guide Wire

Manufacturer:

ABBOTT VASCULAR.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

HI-TORQUE VERSATURN Guide Wire

Manufacturer:

ABBOTT VASCULAR.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 8, 2023

HI-TORQUE Winn 200T Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 4, 2023

ARCHITECT Sirolimus Whole Blood Precipitation Reagent

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2023

ALINITY i Sirolimus Whole Blood Precipitation Reagent

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 26, 2023

ARMADA 18 PTA Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 26, 2023

ALINITY i Cyclosporine Whole Blood Precipitation Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 26, 2023

ALINITY i Sirolimus Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

ARCHITECT Sirolimus Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

ARCHITECT HBsAg Next Confirmatory Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 18, 2023

ARCHITECT HBsAg Next Qualitative Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 18, 2023

HI-TORQUE Balance Middleweight Universal II Guide Wire

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2023

ARMADA 14 XT PTA Catheter

Manufacturer:

ABBOTT VASCULAR COSTA RICA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2023

ABBOTT ICT Sample Diluent

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2023

ARCHITECT HBsAg Next Confirmatory Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 8, 2023

ARCHITECT HBSAg Next Qualitative Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

ALINITY i STAT Myoglobin Calibrators

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

ARCHITECT iDigoxin Reagent Kit

Manufacturer:

BIOKIT S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2023

ARCHITECT Anti-Tg Reagent Kit

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2023

ARCHITECT iDigoxin Calibrators

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2023

NC Trek Neo Coronary Dilation Catheter

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

ARCHITECT Insulin Controls

Manufacturer:

DENKA SEIKEN CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

ARCHITECT Insulin Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

ARCHITECT Phosphorus2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

ALINITY c Phosphorus2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

ARCHITECT Insulin Reagent Kit

Manufacturer:

DENKA SEIKEN CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

ALINITY m Resp-4-Plex CTRL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2023

ABBOTT Alinity m Resp-4-Plex AMP Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2023

ALINITY i ProGRP Calibrators

Manufacturer:

DENKA CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2023

ALINITY c D-Dimer Controls

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 20, 2023

Xience Skypoint Everolimus Eluting Coronary Stent System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 9, 2023

ARCHITECT Estradiol Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 25, 2023

ARCHITECT Urine NGAL Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2023

ALINITY i Insulin Calibrators

Manufacturer:

DENKA, CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2023

ARCHITECT Urine NGAL Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

ARCHITECT Folate Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

ARCHITECT Insulin Controls

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2023

ALINITY i ProGRP Reagent Kit

Manufacturer:

DENKA CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 3, 2023

ALINITY i ProGRP Controls

Manufacturer:

DENKA CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 3, 2023

ARCHITECT Lipid Multiconstituent Calibrator

Manufacturer:

RANDOX LABORATORIES, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 23, 2023

Alinity h-series HGB Reagent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

CELL-DYN Emerald 22 DILUENT

Manufacturer:

AVANTOR PERFORMANCE MATERIALS POLAND S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

ABBOTT Urine/CSF Protein Calibrator

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2023

ARCHITECT iPhenobarbital Reagent Kit

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

Alinity h-series Retic Reagent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

ABBOTT CELL-DYN 18 Plus Calibrator

Manufacturer:

LINE.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

ALINITY i Methotrexate Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2022

ALINITY i Methotrexate Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2022

ALINITY i Methotrexate Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2022

ALINITY and DIGIT 21-1 Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2022

ALINITY and CYFRA 21-1 Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2022

Alinity c Total Bile Acids Reagent Kit

Manufacturer:

SENTINEL CH. S.P.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

Abbott Alinity m STI CTRL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

Abbott Alinity m STI AMP Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

ALINITY i DHEA-S Calibrators

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

ALINITY i DHEA-S Controls

Manufacturer:

BIOKIT, S.A

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

ALINITY i SCC Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

Alinity i NSE Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 24, 2022

Alinity i NSE Controls

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 24, 2022

ALINITY c Specific Proteins Multiconstituent Calibrator Kit

Manufacturer:

NITTOBO MEDICAL CO., LTD MEDICAL DEVELOPMENT CENTER.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

ALINITY i PIVKA-II Calibrators

Manufacturer:

DENKA SEIKEN CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

ALINITY i PIVKA-II Controls

Manufacturer:

DENKA SEIKEN CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

ARCHITECT Multi-Assay Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2022

ARCHITECT ProGRP Calibrators

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2022

ARCHITECT ProGRP Controls

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2022

ARCHITECT ProGRP Reagent Kit

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2022

Abbott Alinity m HR HPV AMP Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2022

ALINITY i Folate Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2022

CELL-DYN Reticulocyte Reagent (CELL-DYN Sapphire Systems)

Manufacturer:

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

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 26, 2022

Abbott Alinity m HCV AMP Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 26, 2022

ALINITY i Anti TPO Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ARCHITECT Tacrolimus Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2022

ALINITY i Urine NGAL Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2022

CELL-DYN Reticulocyte Reagent

Manufacturer:

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

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 21, 2022

ALINITY i Urine NGAL Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2022

ALINITY i Urine NGAL Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2022

ARCHITECT B12 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 18, 2022

ALINITY i B12 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

ALINITY i B12 Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

CELL-DYN Emerald 22 Easy Cleaner

Manufacturer:

AVANTOR PERFORMANCE MATERIALS POLAND S.A

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 16, 2022

ALINITY i B12 Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

Abbott Alinity m HBV AMP Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2022

ALINITY h-series AutoClean Solution

Manufacturer:

AUG. HEDINGER GMBH & CO. Medical history.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 12, 2022

Abbott Alinity m Bottle for Ethanol Use

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 25, 2022

Abbott Alinity m HIV-1 CTRL Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2022

ALINITY c Gamma-Glutamyl Transferase2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2022

ALINITY i HSV-2 IgG Calibrator

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 14, 2022

ARCHITECT B12 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

ALINITY i HSV-2 IgG Reagent Kit

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 14, 2022

ALINITY i HSV-1 IgG Controls

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 14, 2022

Abbott Alinity m Specimen Dilution Kit I

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 14, 2022

ARCHITECT TRAb Controls

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

Abbott Alinity m System

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2022

Abbott Alinity m Sample Prep Kit 2

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 6, 2022

Abbott Alinity m Vapor Barrier Solution

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 6, 2022

ALINITY i HSV-1 IgG Calibrator

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 6, 2022

ALINITY i HSV-1 IgG Reagent kit

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 6, 2022

ALINITY i HSV-2 IgG Controls

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 5, 2022

ARCHITECT TRAb Calibrators

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2022

ARCHITECT TRAb Reagent Kit

Manufacturer:

DENKA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2022

Abbott Alinity m Ethanol Solution

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 1, 2022

ARCHITECT HSV-1 IgG Reagent Kit

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 1, 2022

Abbott Alinity m Cervi-Collect Specimen Collection Kit

Manufacturer:

ABBOTT MOLECULAR, INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 1, 2022

ARCHITECT HSV-2 IgG Controls

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 29, 2022

ARCHITECT HSV-2 IgG Calibrator

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 29, 2022

ARCHITECT HSV-1 IgG Calibrator

Manufacturer:

BIOKIT S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 27, 2022

ARCHITECT Estradiol Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

ARCHITECT Estradiol Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2022

ALINITY i Anti-HBs Specimen Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 18, 2022

ALINITY h-series WBC Reagent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2022

ALINITY h-series Retic Reagent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 17, 2022

ABBOTT FreeStyle Lancing Device II

Manufacturer:

OWEN MUMFORD, LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 2, 2022

ALINITY hs Slide Maker Stainer Module and Accessories

Manufacturer:

SANMINA-SCI SYSTEMS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2022

ARCHITECT Total T3 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2022

ARCHITECT Free T3 Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2022

ALINITY h-series Diluent

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2022

ALINITY c Total Bilirubin Reagent Kit

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I., INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2021

CELL-DYN Emerald Analyzer and Accessories

Manufacturer:

BIT GRUP INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 15, 2021

ARCHITECT Active-B12 (Holotranscobalamin) Controls

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2021

ABBOTT Complement C4

Manufacturer:

ABBOTT LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2021

ABBOTT Complement C3

Manufacturer:

ABBOTT LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2021

ARCHITECT Active-B12 (Holotranscobalamin) Calibrators

Manufacturer:

AXIS-SHIELD DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 12, 2021

ABBOTT WBC Lyse (CellDyn Ruby, CellDyn 3200 Systems

Manufacturer:

ABBOTT LABORATORIES.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2021

ARCHITECT Anti-HBs Specimen Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2021

ABBOTT Microalbumin

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2021

MICROALBUMIN Calibrators

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2021

ABBOTT Immunoglobulin A

Manufacturer:

FISHER DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2021

ARCHITECT Homocysteine Reagent Kit

Manufacturer:

AXIS SHIELD DIAGNOSTICS LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2021

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

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

ARCHITECT B.R.A.H.M.S PCT Reagent Kit

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2021

Alinity c IgE Reagent Kit

Manufacturer:

BIOKIT, S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2021

ABBOTT SARS-CoV-2 IgG II Quant Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2021

ABBOTT SARS-CoV-2 IgG II Quant Calibrator Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2021

ABBOTT SARS-CoV-2 IgG II Quant Control Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2021

ALINITY i HBsAg Qualitative II Confirmatory Manual Diluent

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2021

Mitraclip G4 XT Clip Delivery System

Manufacturer:

ABBOTT VASCULAR

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 16, 2021

ALINITY i T-Uptake Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2021

ALINITY i STAT High Sensitive Troponin-I Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2021

ALINITY i Total B-hCG Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2021

Alinity c Urea Nitrogen2

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2021

ALINITY c-series Maintenance Solutions

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 7, 2021

ALINITY i TSH Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2021

ARCHITECT FSH Controls

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2021

ALINITY i TSH Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2021

ALINITY i SARS-CoV-2 IgM Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2021

ALINITY i SARS-CoV-2 IgG Calibrator Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2021

ABBOTT SARS-CoV-2 IgM Control Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2021

ABBOTT SARS-CoV-2 IgM Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 3, 2021

ABBOTT SARS-CoV-2 IgM Calibrator Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2021

CELL DYN Emerald 22 Easy Cleaner

Manufacturer:

AVANTOR PERFORMANCE MATERIALS POLAND S.A

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 17, 2021

ABBOTT SARS-CoV-2 IgG Reagent Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

ARCHITECT AFP Calibrators

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2021

ALINITY c-series Acid Probe Wash

Manufacturer:

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

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 13, 2021

ALINITY c-series Alkaline Wash

Manufacturer:

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

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 13, 2021

ALINITY c-series Detergent A

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2021

ARCHITECT Probe Conditioning Solution

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 8, 2021

ALINITY c-series Detergent B

Manufacturer:

SEKISUI DIAGNOSTICS P.E.I. INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 3, 2021

ABBOTT SARS-CoV-2 IgG Calibrator Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 3, 2021

ARCHITECT Tacrolimus Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 19, 2021

ALINITY i Tacrolimus Whole Blood Precipitation Reagent

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2020

ALINITY i Tacrolimus Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 10, 2020

ALINITY i Sirolimus Reagent Kit

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 3, 2020

ALINITY i SARS-CoV-2 IgG Control Kit

Manufacturer:

ABBOTT IRELAND DIAGNOSTICS DIVISION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2020

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

Last updated: December 2025