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PT. MRK DIAGNOSTICS

Authorized Representative in Indonesia

JL. Merpati Mas I Blok B1 NO.46 Perkantoran Tanjung Mas Raya Tanjung Barat
134 Products Represented
23 Manufacturers
Total Products
134
Manufacturers
23
Product Classes
2
Risk Classes
3
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
6 products
4.5%
Kelas Resiko : B
105 products
78.4%
Kelas Resiko : C
23 products
17.2%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (134)
Complete portfolio registered with BPOM

MAX 9k Multi Array Xplorer

Manufacturer:

MACROARRAY DIAGNOSTICS (MADX)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2024

ALEX² Allergy Xplorer

Manufacturer:

MACROARRAY DIAGNOSTICS (MADX)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2024

FOOD DETECTIVE™ Professional

Manufacturer:

OMEGA DIAGNOSTICS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

FOODPRINT Microarray 200 + Food IgG ELISA

Manufacturer:

OMEGA DIAGNOSTICS LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

BOULE Cleaning Kit

Manufacturer:

BOULE MEDICAL AB

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 24, 2024

BLUEDOT ANA + DFS-70 IgG

Manufacturer:

D-TEK SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

BLUEDIVER Quantrix Liver 10 IgG

Manufacturer:

D-TEK SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2023

MEDI-TEST Control N & P

Manufacturer:

MACHEREY NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

BlueDiver Quantrix ANA19 IgG

Manufacturer:

D-TEK SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2023

BLUEDIVER DOT ANA+DFS-70 IgG

Manufacturer:

D-TEK SA.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2023

BLUEDIVER Instrument

Manufacturer:

D-TEK SA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2023

URYXXON 500

Manufacturer:

MACHEREY NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2023

MEDI-TEST Combi 3A ( Protein, Ascorbic acid, Glucose, pH )

Manufacturer:

MACHEREY NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2023

MEDI-TEST Glucose

Manufacturer:

MACHEREY NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2023

MEDI-TEST URYXXON Stick 10 (Blood, Urobilinogen, Bilirubin, Protein, Nitrit, Keton, Glucose, pH, Density, Leukocytes)

Manufacturer:

MACHEREY NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2023

EASYCleaner BALL

Manufacturer:

BOULE MEDICAL AB

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 27, 2023

ELITECH MICROALBUMIN IP For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2023

ELITECH TRANSFERRIN For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2023

ELITECH Direct TIBC For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

ELITECH Direct Bilirubin For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

ELITECH TOTAL PROTEIN For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

ELITECH TOTAL BILIRUBIN For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

ELITECH TRIGLYCERIDES For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

ELITECH HDL CHOLESTEROL For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

ELITECH LDL CHOLESTEROL For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ELITECH URIC ACID For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ELITECH CHOLESTEROL For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2023

ELITECH UREA For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2023

ELITECH ALT/GPT For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2023

ELITECH CREATININE PAP For MACH Series

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2023

CerTest Clostridium difficile Toxin A+B

Manufacturer:

CERTEST BIOTEC S.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ELITECH Bilirubin Direct

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

ELITECH LDH-L SL

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

ELITECH CK-MB SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

ELITECH Glucose PAP SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 26, 2022

ELITECH AST/GOT 4+1 SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

ELITECH Direct TIBC

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

ELITECH Gamma GT Plus SL

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

ELITECH Elitrol I

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2022

ELITECH Urea UV SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2022

ELITECH Creatinine Jaffe

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2022

ELITECH Urea UV SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2022

ELITECH Glucose HK SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2022

ELITECH Triglycerides SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ELITECH Triglycerides Mono SL New

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ELITECH Phosporus

Manufacturer:

ELITECH CLINICAL SYSTEM SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ELITECH Rheumatology Control II

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 29, 2022

ELITECH RF Calibrator

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 29, 2022

ELITECH CRP IP CONTROL I

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

ELITECH Uric Acid Mono SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

ELITECH Phosporus

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

ELITECH Ferritin

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

ELITECH Ferritin Calibrator

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

ELITECH CRP IP CONTROL II

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2022

ELITECH Creatinine PAP SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ELITECH ALP (DEA) S.L.

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ELITECH CK-MB Control

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ELITECH Elical 2

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ELITECH Total Protein Plus

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ELITROL II

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ELITECH Iron Ferene

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ELITECH Calcium Arsenazo

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

ELITECH Albumin

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

ELITECH Bilirubin Total 4 + 1

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

ELITECH Amylase SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

ELITECH Albumin

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

DIAMOND Prolyte Cl- Electrode

Manufacturer:

DIAMOND DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

DIAMOND Prolyte K+ Electrode

Manufacturer:

DIAMOND DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

DIAMOND Prolyte Reference Electrode

Manufacturer:

DIAMOND DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2022

MISSION CONTROL Level 2

Manufacturer:

DIAMOND DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 11, 2022

MISSION CONTROL Level 1

Manufacturer:

DIAMOND DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2022

MISSION CONTROL™ Level 1-2-3

Manufacturer:

DIAMOND DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 12, 2022

DIAMOND Fluid Pack

Manufacturer:

DIAMOND DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

PROLYTE Electrolyte Analyzer and Accessories

Manufacturer:

DIAMOND DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

CERTEST FOB

Manufacturer:

CERTEST BIOTEC S.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 21, 2022

CERTEST Calprotectin + Lactoferrin

Manufacturer:

CERTEST BIOTEC S.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

CERTEST Calprotectin

Manufacturer:

CERTEST BIOTEC S.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

SELECTRA MACH5

Manufacturer:

ELITECH GROUP BV

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2022

Cellbind Incubator

Manufacturer:

HANGZHOU ALLSHENG INSTRUMENTS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 28, 2021

ELITECH Cholesterol SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2021

ELITech URIC ACID SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2021

ELITECH Uric Acid Mono SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2021

ELITech CK NAC SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2021

ELITech LDL CHOLESTEROL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2021

ELITECH ALT/GPT 4+1 SL

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2021

ELITECH Bilirubin Direct 4 + 1

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2021

ELITech System Solution

Manufacturer:

ELITECH CLINICAL SYSTEMS SAS.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 14, 2021

MEDI-TEST Control N & P

Manufacturer:

MACHEREY-NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2021

URYXXON 500

Manufacturer:

MACHEREY NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

URYXXON Relax

Manufacturer:

MACHEREY NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2021

MEDI-TEST URYXXON Stick 10 (Blood, Urobilinogen, Bilirubin, Protein, Nitrit, Keton, Glucose, pH, Density, Leukocytes)

Manufacturer:

MACHEREY-NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2021

MEDI-TEST Glucose

Manufacturer:

MACHEREY NAGEL GMBH & CO., KG.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2021

BOULE Con-5Diff A1 Norm

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2021

BOULE Con-5Diff A1 Low

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2021

ELITech HDL LDL Calibrator

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2021

BALL Con-5Diff A1 Tri

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2021

BALL Cal-5Diff A1

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2021

BOULE Con-Diff Low

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2021

MEDONIC M-Series Dualpack 200 BALL

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2021

BALL Con-Diff Normal

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2021

BALL Con-Diff Tri Level

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2021

BALL Cal

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2021

BOULE Con-Diff High

Manufacturer:

BOULE MEDICAL.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

Pelikloon Control Monoclonal

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

ELITECH SELECTRA PRO S and Accessories

Manufacturer:

ELITECH GROUP BV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2021

Cellbind Direct

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 12, 2021

Cellbind Direct Type

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 12, 2021

MICROLAB 300 LX Semi Automated Clinical Chemistry Analyzer and Accessories

Manufacturer:

ELITECH GROUP BV.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 3, 2021

ELITech HDL Cholesterol

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 2, 2021

ELITECH SELECTRA Pro XS

Manufacturer:

ELITECH GROUP BV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2021

ELITECH SELECTRA PRO XL and Accessories

Manufacturer:

ELITECH GROUP BV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 25, 2021

MICROLAB 300 and Accessories

Manufacturer:

ELITECH GROUP BV.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 10, 2021

ELITECH SELECTRA PRO M and Accessories

Manufacturer:

ELITECH GROUP BV.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

Pelikloon anti-B (IgM) monoclonal

Manufacturer:

SANQUIN REAGENTS B.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 1, 2020

Cellbind A1 Reagent Red Cells

Manufacturer:

SANQUIN REAGENTS B.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2020

Cellbind P2

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2020

Pelikloon anti-D (IgM) monoclonal

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 26, 2020

Pelikloon anti-A (IgM) monoclonal

Manufacturer:

SANQUIN REAGENTS B.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2020

Pelikloon anti-A,B (IgM) monoclonal

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2020

Cellbind B Reagent Red Cells

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2020

Cellbind P3

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2020

Cellbind Screen

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2020

Cellbind LISS

Manufacturer:

SANQUIN REAGENTS B.V.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2020

ELITECH CRP IP

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2020

ELITECH VITAMIN D CALIBRATOR SET

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2020

ELITECH VITAMIN D

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2020

ELITECH CRP IP Calibrator Set

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2020

ELITECH Vitamin D Control Set

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2020

ELITECH ALP IFCC

Manufacturer:

ELITECH CLINICAL SYSTEM SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2020

VITROS 5600 Integrated System

Manufacturer:

NPA DE MEXICO S. DE R.L. DE C.V

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2019

VITROS Chemistry Products Electrolyte Reference Fluid (ERF) 300

Manufacturer:

ORTHO CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2019

VITROS Chemistry Products Electrolyte Reference Fluid (ERF) 800

Manufacturer:

ORTHO CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2019

ORTHO Pooled Screening Cells

Manufacturer:

ORTHO CLINICAL DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 6, 2019

VITROS Chemistry Products LDHI Slides

Manufacturer:

ORTHO CLINICAL DIAGNOSTICS. INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2019

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

Last updated: December 2025