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EMERALINDO ASIA PACIFIC

Authorized Representative in Indonesia

RUKAN PERMATA SENAYAN BLOK G15, Lantai 1, JL.TENTARA PELAJAR NO. 5, Desa/Kelurahan Grogol Utara, Kec. Kebayoran Lama, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta Kode Pos: 12210
209 Products Represented
22 Manufacturers
Total Products
209
Manufacturers
22
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
6 products
2.9%
Kelas Resiko : B
145 products
69.4%
Kelas Resiko : C
50 products
23.9%
Kelas Resiko : D
8 products
3.8%
Manufacturer Portfolio
Products organized by manufacturer
99 Products

VITROS Immunodiagnostic Products System Cleaning Solution

Kelas Resiko : A
Jun 18, 2024

VITROS Immunodiagnostic Products Rubella IgM Reagent Pack

Kelas Resiko : C
Jun 10, 2024

VITROS Immunodiagnostic Products Rubella IgM Calibrator

Kelas Resiko : C
Jun 10, 2024

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack

Kelas Resiko : D
Jun 10, 2024

VITROS Immunodiagnostic Products Free PSA Reagent Pack

Kelas Resiko : C
Jun 7, 2024
View all 99 products from this manufacturer →
36 Products

VITROS Chemistry Products Calibrator Kit 4

Kelas Resiko : B
May 17, 2024

VITROS Chemistry Products Calibrator Kit 7

Kelas Resiko : B
Mar 24, 2024

VITROS Chemistry Products C3 Reagent

Kelas Resiko : B
Mar 18, 2024

VITROS Chemistry Products UPRO Performance Verifier II

Kelas Resiko : B
Mar 18, 2024

VITROS Chemistry Products Mg Slides

Kelas Resiko : B
Mar 8, 2024
View all 36 products from this manufacturer →
21 Products

VITROS Chemistry Products Liquid Performance Verifier II

Kelas Resiko : B
Mar 24, 2024

VITROS Chemistry Products mALB Performance Verifier I

Kelas Resiko : B
Mar 24, 2024

VITROS Chemistry Products Calibrator Kit 29

Kelas Resiko : B
Mar 8, 2024

VITROS Chemistry Products % A1c Performance Verifier II

Kelas Resiko : B
Mar 1, 2024

VITROS Chemistry Products TDM Performance Verifier II

Kelas Resiko : B
Feb 26, 2024
View all 21 products from this manufacturer →
17 Products

VITROS Immunodiagnostic Products Universal Wash Reagent

Kelas Resiko : A
Jun 4, 2024

VITROS Chemistry Products Immuno-Wash Fluid

Kelas Resiko : A
May 21, 2024

VITROS Chemistry Products A1c Slides

Kelas Resiko : B
Apr 5, 2024

VITROS Chemistry Products hsCRP Performance Verifier I

Kelas Resiko : B
Mar 27, 2024

VITROS Chemistry Products hsCRP Reagent

Kelas Resiko : B
Mar 26, 2024
View all 17 products from this manufacturer →
5 Products

VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator

Kelas Resiko : B
May 7, 2024

VITROS Immunodiagnostic Products TSH3 Reagent Pack

Kelas Resiko : B
Apr 17, 2024

VITROS Immunodiagnostic Products C-peptide Reagent Pack

Kelas Resiko : B
Apr 17, 2024

VITROS Immunodiagnostic Products BRAHMS PCT Calibrators

Kelas Resiko : B
Apr 6, 2024

Neutral Ortho BioVue® System (Neutral Cassette)

Kelas Resiko : C
Jul 22, 2022
5 Products

VITROS Chemistry Products dLDL Reagent

Kelas Resiko : B
Mar 20, 2024

VITROS Chemistry Products CRP Performance Verifier I

Kelas Resiko : B
Mar 13, 2024

VITROS Chemistry Products CRP slides

Kelas Resiko : B
Mar 13, 2024

VITROS Chemistry Products PHOS Slides

Kelas Resiko : B
Mar 8, 2024

ORTHO® 0.8% Red Cell Diluent

Kelas Resiko : C
Sep 13, 2022
5 Products

VITROS Immunodiagnostic Products CA 125 II Calibrators

Kelas Resiko : C
Nov 16, 2023

VITROS Immunodiagnostic Products CA 19-9™ Calibrators

Kelas Resiko : C
Nov 16, 2023

VITROS Immunodiagnostic Products CA 125 II Reagent Pack

Kelas Resiko : C
Nov 15, 2023

VITROS Immunodiagnostic Products CA 15-3 ™ Calibrators

Kelas Resiko : C
Jul 29, 2023

VITROS Immunodiagnostic Products CA 15-3™ Reagent Pack

Kelas Resiko : C
Jul 29, 2023
3 Products

VITROS Immunodiagnostic Products Total Thyroid Controls

Kelas Resiko : B
Apr 5, 2024

VITROS Immunodiagnostic Products TSH Reagent Pack

Kelas Resiko : B
Mar 29, 2024

VITROS Immunodiagnostic Products TSH Calibrator

Kelas Resiko : B
Mar 29, 2024
3 Products

VITROS ECiQ Immunodiagnostic System

Kelas Resiko : B
Feb 9, 2024

VITROS XT 7600 Integrated System

Kelas Resiko : B
Jan 25, 2024

VITROS 350 Chemistry System and Accessories

Kelas Resiko : B
Jan 25, 2024
MILLIPORE UK LTD

United Kingdom

2 Products

ORTHO BLISS

Kelas Resiko : C
Feb 1, 2024

BIOCLONE Anti-Kell (Kel1) Monoclonal IgM (human)

Kelas Resiko : C
Jul 4, 2023
ALBA BIOSCIENCE LTD

United Kingdom

2 Products

ORTHO WILL BE Anti-D DVI

Kelas Resiko : C
Nov 15, 2023

ORTHO WILL BE Anti-D IAT

Kelas Resiko : C
Nov 15, 2023
1 Products

VITROS Chemistry Products wrCRP Reagent

Kelas Resiko : B
Aug 27, 2024
1 Products

VITROS Chemistry Products mALB Performance Verifier II

Kelas Resiko : B
Mar 24, 2024
1 Products

VITROS Chemistry Products Calibrator Kit 9

Kelas Resiko : B
Mar 24, 2024
1 Products

VITROS Chemistry Products ALB Slides

Kelas Resiko : B
Mar 18, 2024
1 Products

VITROS 5600 Integrated System and Accessories

Kelas Resiko : B
Feb 2, 2024
1 Products

VITROS Chemistry Products LDHI Slides

Kelas Resiko : B
Feb 1, 2024
CLINIQA CORPORATION

United States

1 Products

CLINIQA Liquid QC® Cardiac Marker Control VS

Kelas Resiko : B
Feb 1, 2024
1 Products

ORTHO OPTIX ™ Reader BioVue

Kelas Resiko : C
Jan 31, 2024
1 Products

VITROS Immunodiagnostic Products CA 19-9 ™ Reagent Pack

Kelas Resiko : C
Nov 15, 2023
1 Products

VITROS Chemistry Products PHYT Slides

Kelas Resiko : B
Jul 11, 2023
1 Products

Blood Grouping Reagents Anti-A/Anti-B/Anti-A,B/Anti-D/Control Anti-IgG Ortho BioVue System Newborn Cassette

Kelas Resiko : C
Jul 14, 2022
All Represented Products (209)
Complete portfolio registered with BPOM

VITROS Chemistry Products wrCRP Reagent

Manufacturer:

SENTINEL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 27, 2024

VITROS Immunodiagnostic Products System Cleaning Solution

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 18, 2024

VITROS Immunodiagnostic Products Rubella IgM Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2024

VITROS Immunodiagnostic Products Rubella IgM Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2024

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 10, 2024

VITROS Immunodiagnostic Products Free PSA Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2024

VITROS Immunodiagnostic Products HBeAg Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 7, 2024

VITROS Immunodiagnostic Products Total T3 Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

VITROS Immunodiagnostic Products LH Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

VITROS Immunodiagnostic Products Testosterone Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2024

VITROS Immunodiagnostic Products Universal Wash Reagent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 4, 2024

VITROS Immunodiagnostic Products FSH Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2024

VITROS Immunodiagnostic Products HIV Combo Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2024

VITROS Immunodiagnostic Products FSH Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2024

VITROS Immunodiagnostic Products T3 Uptake Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2024

VITROS Immunodiagnostic Products HIV Combo Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 30, 2024

VITROS Immunodiagnostic Products HIV Combo Controls (Anti-HIV-1 group O)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

VITROS Immunodiagnostic Products Testosterone Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

VITROS Immunodiagnostic Products LH Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

VITROS Immunodiagnostic Products Metabolism Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2024

VITROS Immunodiagnostic Products CEA Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2024

VITROS Immunodiagnostic Products Testosterone Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2024

VITROS Immunodiagnostic Products Anti-HBc Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2024

VITROS Immunodiagnostic Products Anti-HBc Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2024

VITROS Immunodiagnostic Products Anti-HBe Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 21, 2024

VITROS Chemistry Products Immuno-Wash Fluid

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 21, 2024

VITROS Immunodiagnostic Products Anti-HCV Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 21, 2024

VITROS Immunodiagnostic Products Toxoplasma IgM Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

VITROS Immunodiagnostic Products Toxoplasma IgG Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

VITROS Immunodiagnostic Products Ferritin Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 18, 2024

VITROS Immunodiagnostic Products Total T3 Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 18, 2024

VITROS Immunodiagnostic Products Estradiol Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2024

VITROS Immunodiagnostic Products Free T3 Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2024

VITROS Immunodiagnostic Products Rubella IgG Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2024

VITROS Immunodiagnostic Products Total PSA II Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2024

VITROS Immunodiagnostic Products Ferritin Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2024

VITROS Immunodiagnostic Products Estradiol Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2024

VITROS Immunodiagnostic Products AFP Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2024

VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2024

VITROS Immunodiagnostic Products Free T3 Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2024

VITROS Chemistry Products Calibrator Kit 4

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2024

VITROS Immunodiagnostic Products RE Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2024

VITROS Immunodiagnostic Products Anti-HBe Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

VITROS Immunodiagnostic Products Total β -hCG II Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

VITROS Immunodiagnostic Products Total β -hCG II Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

VITROS Immunodiagnostic Products Total PSA II Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2024

VITROS Immunodiagnostic Products AFP Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

VITROS Immunodiagnostic Products Anti-HAV Total Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

VITROS Immunodiagnostic Products CEA Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

VITROS Immunodiagnostic Products Anti-HAV IgM Control

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

VITROS Immunodiagnostic Products Anemia Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 30, 2024

VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 30, 2024

VITROS Immunodiagnostic Products CMV IgM Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

VITROS Immunodiagnostic Products TSH3 Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2024

VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2024

VITROS Immunodiagnostic Products hs Troponin I Low Control

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2024

VITROS Immunodiagnostic Products NT-proBNP II Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2024

VITROS Immunodiagnostic Products Syphilis TPA Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 24, 2024

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 24, 2024

VITROS Immunodiagnostic Products Insulin Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

VITROS Immunodiagnostic Products Insulin Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

VITROS Immunodiagnostic Products Total T4 Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2024

VITROS Immunodiagnostic Products NT-proBNP II Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2024

VITROS Immunodiagnostic Products Syphilis TPA Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2024

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2024

VITROS Immunodiagnostic Products Free Thyroid Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2024

VITROS Immunodiagnostic Products C-Peptide Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 17, 2024

VITROS Immunodiagnostic Products TSH3 Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 17, 2024

VITROS Immunodiagnostic Products C-peptide Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 17, 2024

VITROS Immunodiagnostic Products Anti-HBs Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

VITROS Immunodiagnostic Products Anti-HBs Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

VITROS Immunodiagnostic Products HBsAg ES Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Apr 7, 2024

VITROS Immunodiagnostic Products Free T4 Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2024

VITROS Immunodiagnostic Products BRAHMS PCT Control

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2024

VITROS Immunodiagnostic Products BRAHMS PCT Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2024

VITROS Immunodiagnostic Products Total T4 Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

VITROS Immunodiagnostic Products Free T4 Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

VITROS Chemistry Products A1c Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

VITROS Immunodiagnostic Products hs Troponin I Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

VITROS Immunodiagnostic Products Total Thyroid Controls

Manufacturer:

ORTHO - CLINICAL DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2024

VITROS Immunodiagnostic Products Syphilis TPA Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 29, 2024

VITROS Immunodiagnostic Products TSH Reagent Pack

Manufacturer:

ORTHO - CLINICAL DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2024

VITROS Immunodiagnostic Products TSH Calibrator

Manufacturer:

ORTHO - CLINICAL DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2024

VITROS Chemistry Products hsCRP Performance Verifier I

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2024

VITROS Chemistry Products hsCRP Reagent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 26, 2024

VITROS Chemistry Products Calibrator Kit 33

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 26, 2024

VITROS Immunodiagnostic Products Anti-HCV Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

VITROS Chemistry Products Liquid Performance Verifier II

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

VITROS Chemistry Products mALB Performance Verifier I

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

VITROS Chemistry Products Calibrator Kit 7

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

VITROS Chemistry Products hsCRP Performance Verifier II

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

VITROS Chemistry Products mALB Performance Verifier II

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC. (1000 LEE RD. ROCHESTER)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

VITROS Chemistry Products Calibrator Kit 9

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC (LEE ROAD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

VITROS Chemistry Products Calibrator Kit 17

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

VITROS Immunodiagnostic Products HBsAg ES Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 24, 2024

VITROS Chemistry Products PROT Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 20, 2024

VITROS Chemistry Products dLDL Reagent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 20, 2024

VITROS Chemistry Products CRBM Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

VITROS Chemistry Products C3 Reagent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

VITROS Chemistry Products ALB Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC (BLVD)

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

VITROS Chemistry Products UPRO Performance Verifier II

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2024

VITROS Chemistry Products CRP Performance Verifier I

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

VITROS Chemistry Products CRP slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

VITROS Chemistry Products Mg Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

VITROS Chemistry Products Calibrator Kit 5

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

VITROS Chemistry Products PHOS Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

VITROS Chemistry Products Calibrator Kit 29

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2024

VITROS Chemistry Products UPRO Performance Verifier I

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 4, 2024

VITROS Immunodiagnostic Product Signal Reagent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 1, 2024

VITROS Chemistry Products AMON Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

VITROS Chemistry Products % A1c Performance Verifier II

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

VITROS Chemistry Products Na+ Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products TDM Performance Verifier II

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products CHE Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 26, 2024

VITROS Chemistry Products Urine Electrolyte Diluent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products GGT Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products Ca Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products AMYL Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products ALC Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products Calibrator Kit 8

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products BuBc Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products Performance Verifier II

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products CKMB Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

VITROS Chemistry Products K+ Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

VITROS Chemistry Products URIC Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 14, 2024

VITROS Chemistry Products CREA Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 14, 2024

VITROS Chemistry Products 7% BSA

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2024

VITROS ECiQ Immunodiagnostic System

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2024

VITROS Chemistry Products Performance Verifier I

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2024

VITROS Chemistry Products Calibrator Kit 6

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2024

VITROS Chemistry Products TRIG Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2024

VITROS Chemistry Products BUN/UREA Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2024

VITROS Chemistry Products dHDL Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2024

VITROS Chemistry Products CHOL Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2024

VITROS Immunodiagnostic Products HBsAg ES Confirmatory Kit

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 6, 2024

ORTHO™ 7% BSA Reagent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 5, 2024

VITROS 5600 Integrated System and Accessories

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2024

ORTHO BLISS

Manufacturer:

MILLIPORE UK LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2024

VITROS Chemistry Products LDHI Slides

Manufacturer:

ORTHO CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

VITROS Chemistry Products Calibrator Kit 3

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

VITROS Chemistry Products Calibrator Kit 2

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

CLINIQA Liquid QC® Cardiac Marker Control VS

Manufacturer:

CLINIQA CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

VITROS Chemistry Products ALKP Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

VITROS Chemistry Products ALTV Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

ORTHO OPTIX ™ Reader BioVue

Manufacturer:

MACK MOLDING COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2024

VITROS XT 7600 Integrated System

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2024

VITROS 350 Chemistry System and Accessories

Manufacturer:

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

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2024

ORTHO Reverse Diluent Ortho BioVue® System (Reverse Diluent Cassette)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2024

VITROS Chemistry Products Calibrator Kit 1

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2024

VITROS Immunodiagnostic Products Nephrocheck Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2024

ORTHO Blood Grouping Reagents Anti-A/Anti-B/Anti-D Control / Reverse Diluent Ortho BioVue® System (ABO-Rh/Reverse Grouping Cassette)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2024

VITROS Immunodiagnostic Products IL-6 Calibrator

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2024

VITROS Immunodiagnostic Products NTx Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2024

VITROS Immunodiagnostic Products NTx Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2024

VITROS Immunodiagnostic Products IL-6 Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 17, 2024

VITROS XT Chemistry Products TRIG-CHOL Slide

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2023

VITROS Immunodiagnostic Products Intact PTH Reagent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2023

VITROS XT Chemistry Products ALB-TP Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

VITROS Chemistry Products C4 Reagent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

VITROS Chemistry Products TDM Performance Verifier I

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

VITROS Immunodiagnostic Products CK-MB Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

VITROS Immunodiagnostic Products CK-MB Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2023

VITROS Immunodiagnostic Products CMV IgG Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2023

VITROS Immunodiagnostic Products CA 125 II Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2023

VITROS Immunodiagnostic Products CA 19-9™ Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2023

VITROS Immunodiagnostic Products CA 125 II Reagent Pack

Manufacturer:

FUJIREBIO DIAGNOSTIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2023

ORTHO WILL BE Anti-D DVI

Manufacturer:

ALBA BIOSCIENCE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2023

ORTHO WILL BE Anti-D IAT

Manufacturer:

ALBA BIOSCIENCE LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2023

VITROS Immunodiagnostic Products CA 19-9 ™ Reagent Pack

Manufacturer:

FUJIREBIO DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2023

VITROS Chemistry Products Calibrator Kit 19

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

VITROS Immunodiagnostic Products Prolactin Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

VITROS Immunodiagnostic Products Progesterone Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

VITROS Immunodiagnostic Products Prolactin Reagent Pack

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

VITROS Immunodiagnostic Products CA 15-3 ™ Calibrators

Manufacturer:

FUJIREBIO DIAGNOSTIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2023

VITROS Immunodiagnostic Products CA 15-3™ Reagent Pack

Manufacturer:

FUJIREBIO DIAGNOSTIC, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2023

VITROS Immunodiagnostic Products Toxoplasma IgG Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 17, 2023

VITROS Chemistry Products PHYT Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

VITROS Chemistry Products THEO Slides

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ORTHO Anti-Cellano (Anti-KEL2)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 6, 2023

BIOCLONE Anti-Kell (Kel1) Monoclonal IgM (human)

Manufacturer:

MILLIPORE UK LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 4, 2023

VITROS Immunodiagnostic Products HBe Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2023

VITROS Chemistry Products FS Reconstitution Diluent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

VITROS Chemistry Products FS Diluent Pack 3 (Specialty Diluent/Water)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

VITROS Chemistry Products Calibrator Kit 31

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

ORTHO Anti-s (Anti-MNS4)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 18, 2023

SURGISCREEN

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2023

ORTHO® Pooled Screening Cells

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2022

ORTHO Coombs Control

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2022

ORTHO Reagent Red Blood Cells 0.8% AFFIRMAGEN 4

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2022

ORTHO Reagent Red Blood Cells 0.8% AFFIRMAGEN

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2022

ORTHO Reagent Red Blood Cells 0.8% AFFIRMAGEN 3

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2022

ORTHO Affirmagen

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 29, 2022

ORTHO Anti-IgG

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

Anti-Leb (LE2) BioClone 2.0

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 22, 2022

Anti-Lea (LE1) BioClone 2.0

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2022

ORTHO® 0.8% Red Cell Diluent

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2022

ORTHO Anti-Human Globulin Anti-lgG (Rabbit) (Green) Ortho BioVue System (IgG Cassette)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2022

ORTHO Anti-Human Globulin Anti-lgG, -C3d; polyspecific Ortho BioVue System (Poly Cassette)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 25, 2022

Blood Grouping Reagents Anti-A (Anti-ABO1) Anti-B (Anti-ABO2) Anti-D (Anti-RH1) Ortho BioVue System (ABD Confirmation Cassette)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 22, 2022

Neutral Ortho BioVue® System (Neutral Cassette)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 22, 2022

Blood Grouping Reagents Anti-A/Anti-B/Anti-A,B/Anti-D/Control Anti-IgG Ortho BioVue System Newborn Cassette

Manufacturer:

ORTHO - CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 14, 2022

Blood Grouping Reagent Anti-K (Anti-K1) Ortho BioVue® System (K Cassette)

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 4, 2022

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 14, 2022

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Calibrators

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 14, 2022

Anti-D (Anti-RH1) (Human Monoclonal-Polyclonal Blend) BioClone

Manufacturer:

ORTHO-CLINICAL DIAGNOSTICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 29, 2021

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

Last updated: December 2025