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PT. SUMIFIN CITRA ABADI

Authorized Representative in Indonesia

Jl. Alam Sutera Boulevard Alam Sutera Town Center (ASTC) Blok 10D No.19, Kel. Pakulonan, Kec. Serpong Utara - Tangerang Selatan 15325
207 Products Represented
47 Manufacturers
Total Products
207
Manufacturers
47
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
21 products
10.1%
Kelas Resiko : B
130 products
62.8%
Kelas Resiko : C
47 products
22.7%
Kelas Resiko : D
9 products
4.3%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (207)
Complete portfolio registered with BPOM

DIAFIN DFLC-30 Clinical Centrifuge

Manufacturer:

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 10, 2025

DIAFIN DFLC-22 Low Speed Centrifuge

Manufacturer:

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 10, 2025

DIAFIN DFRC-24A Refrigerated Centrifuge

Manufacturer:

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 10, 2025

DIAFIN DFRC-12A Refrigerated Centrifuge

Manufacturer:

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 5, 2025

ZENIX Glycated Hemoglobin Test kit (HPLC)

Manufacturer:

SHENZHEN XILAIHENG MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

DIAFIN DFRC-12B Refrigerated Centrifuge and Accessories

Manufacturer:

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

INNODX TSH CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2025

ZELL-ESR Erythrocyte Sedimentation Rate Analyzer

Manufacturer:

STERILE SAFEQUIP AND CHEMICALS LLP

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 23, 2025

KEWEI RV-IgM Test Kit

Manufacturer:

BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 22, 2025

DIAFIN DFGC-23 Blood Gel Cards Centrifuge

Manufacturer:

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 7, 2025

LUMIGENEX Creatinine Test Strips (Dry chemical method)

Manufacturer:

LUMIGENEX (SUZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

LUMIGENEX Uric Acid Test Strips (Dry Chemical Method)

Manufacturer:

LUMIGENEX (SUZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

KEWEI RV-IgG Test Kit

Manufacturer:

BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2024

iLONGCARE Total Bilirubin Assay Kit (Vanadate Oxidation Method)

Manufacturer:

SHENZHEN LONGCARE BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

LUMIGENEX Lipid Panel Test Strips (Dry chemical method)

Manufacturer:

LUMIGENEX (SUZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2024

Gcell Liss Coombs (Anti IgG+C3d) Card (Microcolumn Gel Method)

Manufacturer:

BEIJING STRONG BIOTECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2024

iLONGCARE Glucose (GLU) Assay Kit(Glucose Oxidase method)

Manufacturer:

SHENZHEN LONGCARE BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

KEWEI TOX-IgM Test Kit

Manufacturer:

BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

Gcell ABO/RhD Neutral Blood Grouping Card (Microcolumn Gel Method)

Manufacturer:

BEIJING STRONG BIOTECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2024

Gcell ABD Blood Grouping Card (Microcolumn Gel Method)

Manufacturer:

BEIJING STRONG BIOTECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2024

LIQUIZONE Alkaline Phosphatase

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2024

Is It Dengue IgG/IgM Antibody Rapid Test Kit

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2024

ZBT-ESR Erythrocyte Sedimentation Rate Analyzer

Manufacturer:

STERILE SAFEQUIP AND CHEMICALS LLP

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 11, 2024

Is It HBsAg Rapid Test

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 1, 2024

Is It Dengue Combo (NS1 Antigen + IgG/IgM Antibody)

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 30, 2024

MEDICALSYSTEM MS-H655 Automated Hematology Analyzer

Manufacturer:

NINGBO MEDICALSYSTEM BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

LIQUIZONE Cholesterol - MR

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2024

HRJ-BIO Total Protein (TP) Reagent Kit (Biuret Colorimetric Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2024

FOUR E'S Clinical Centrifuge and Accessories

Manufacturer:

GUANGZHOU FOUR E'S SCIENTIFIC CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 12, 2024

Is It Syphilis Test Device

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 4, 2024

Is It Malaria Pf/Pan Antigen

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

Is It Dengue NS1 Antigen

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

Is It Malaria Pf/Pv Antigen

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2024

OZOCLONE B Blood Grouping Sera Anti-B

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 9, 2024

OZOCLONE Anti-D (IgM) Blood Grouping Sera Anti-D (IgM)

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 8, 2024

OZOCLONE A Blood Grouping Sera Anti-A

Manufacturer:

MEDSOURCE OZONE BIOMEDICAL PVT., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

OZOCLONE Anti AB Blood Grouping Sera Anti-AB

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2024

DIAFIN DFRC-24B Refrigerated Centrifuge

Manufacturer:

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 25, 2024

LIQUIZONE Total Protein dan Albumin ( Biuret & BCG Method )

Manufacturer:

MEDSOURCE OZONE BIOMEDICALS PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 11, 2024

INNODX cTnT CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

INNODX Myo CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

VANSFUL URS-3 Reagent Strips For Urinalysis

Manufacturer:

CHANGCHUN WANCHENG BIO-ELECTRON CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2024

INNODX AFP CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2024

ZENIX ZS-11UA Reagent Strips for Urinalysis

Manufacturer:

YERCON DIAGNOSTIC CO,. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 25, 2024

DIAFIN DFGI-23 Blood Gel Cards Incubator

Manufacturer:

CHANGSHA YINGTAI INSTRUMENT CO. LTD.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 19, 2024

INNODX CWS Concentrated Wash Solution

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 18, 2024

INNODX TS Trigger Solution

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 13, 2024

INNODX PTS Pre-trigger Solution

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 6, 2024

HRJ-BIO Low Density Lipoprotein Cholesterol (LDL-C) Reagent Kit (Direct Method

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

ZENIX ZN-588 Full-auto Chemistry Analyzer and Accessories

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

ZENIX ZN-488 Full-auto Chemistry Analyzer and Accessories

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

ZENIX Bright

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2024

ZENIX Diluent

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

ZENIX Cleanser

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO. LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 24, 2024

ZENIX Concentrated Cleanser

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO. LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 24, 2024

HRJ-BIO T-BIL Reagent Kit (Venadate Oxidation Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2024

ZENIX ZS-I Standard A Standard B

Manufacturer:

GENRUI BIOTECH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 19, 2024

ZENIX ZS-ISE Filling Solution

Manufacturer:

GENRUI BIOTECH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 19, 2024

INNODX PCT CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2024

ZENIX ZN-300 Electrolyte Analyzer and Accessories

Manufacturer:

GENRUI BIOTECH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2024

VANSFUL W-600 Urine Analyzer

Manufacturer:

CHANGCUN WANCHENG BIO-ELECTRON CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2024

INNODX CEA CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 3, 2024

INNODX TB-IGRA CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 3, 2024

WAN200+ Fully Automated Chemiluminescence Immunoassay Analyzer and Accessories

Manufacturer:

XIAMEN UNITED MEDICAL INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2023

INNODX HS-CRP CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2023

HRJ-BIO Alanine Aminotransferase (ALT) Reagent Kit (IFCC Kinetic Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

MD Pacific Coagulation Quality Control Plasma Kit (Coagulation)

Manufacturer:

MD PACIFIC (TIANJIN) BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

iLONGCARE DC-200C Auto Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN LONGCARE BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

MD PACIFIC Coagulation Quality Control Plasma Kit (Coagulation)

Manufacturer:

MD PACIFIC (TIANJIN) BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2023

MD PACIFIC Activated Partial Thromboplastin Time (APTT) Assay Kit (Coagulation)

Manufacturer:

MD PACIFIC (TIANJIN) BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

MD PACIFIC Fibrinogen (FIB) Assay Kit (Coagulation)

Manufacturer:

MD PACIFIC (TIANJIN) BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2023

MD PACIFIC Microalbumin (MALB) Kit

Manufacturer:

MD PACIFIC ( TIANJIN ) BIOTECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

MD PACIFIC Prothrombin Time (PT) Assay Kit (Coagulation)

Manufacturer:

MD PACIFIC (TIANJIN) BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

MD PACIFIC Rheumatoid Factor (RF) Kit

Manufacturer:

MD PACIFIC (TIANJIN) BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

DIASINO 25-OH Vitamin D Total ELISA

Manufacturer:

DIASINO LABORATORIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

DIASINO FSH ELISA

Manufacturer:

DIASINO LABORATORIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

DIASINO Testosterone ELISA

Manufacturer:

DIASINO LABORATORIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2023

DIASINO FT3 ELISA

Manufacturer:

DIASINO LABORATORIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2023

DIASINO FT4 ELISA

Manufacturer:

DIASINO LABORATORIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2023

MD PACIFIC C-Reactive protein (CRP) Kit

Manufacturer:

MD PACIFIC (TIANJIN) BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2023

DIASINO TSH ELISA

Manufacturer:

DIASINO LABORATORIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2023

DIASINO T4 ELISA

Manufacturer:

DIASINO LABORATORIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2023

DIASINO T3 ELISA

Manufacturer:

DIASINO LABORATORIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2023

VANSFUL W-200B Urine Analyzer

Manufacturer:

CHANGCUN WANCHENG BIO-ELECTRON CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2023

ZENIX Nucleic Acid Extraction or Purification Kit

Manufacturer:

BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 3, 2023

WAN100 Fully-Automatic Chemiluminescence Immunoassay Analyzer

Manufacturer:

XIAMEN UNITED MEDICAL INSTRUMENTS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2023

YICARE Hemoglobin Test Strip (Dry Chemistry)

Manufacturer:

HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2023

Yicare Hemoglobin Analysis Meter

Manufacturer:

HANGZHOU LYSUN BIOTECHNOLOGY CO,. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 18, 2023

ZENIX-96 Real-Time PCR System

Manufacturer:

BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 17, 2023

ZENIX-32 Automatic Nucleic Acid Extractor

Manufacturer:

YANTAI ADDCARE BIO-TECH LIMITED COMPANY

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2023

INNODX IL-6 CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2023

INNODX Prog CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2023

INNODX Ferritin CMIA

Manufacturer:

XIAMEN INNODX BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2023

HRJ-BIO β-Human Chorionic Gonadotropin (β-HCG) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

HRJ-E900 Electrolyte Reagent

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2023

HRJ-E900 Electrolyte Analyzer and Accessories

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

HRJ-C100 Auto Chemistry Analyzer

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

HRJ-BIO Whole Range C-Reactive Protein (Hs-CRP+CRP) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2023

MEDICALSYSTEM MS-380P Automated Chemistry Analyzer and Accessories

Manufacturer:

NINGBO MEDICALSYSTEM BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

TIANQI MS-5 Semi-automatic Stainer System

Manufacturer:

HUNAN-TECH NEW MEDICAL SYSTEMS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

TIANQI® Interlayer Acid-fast Bacilli Test Kits

Manufacturer:

HUNAN-TECH NEW MEDICAL SYSTEMS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 10, 2023

FOUR E'S Precipette Single Channel Adjustable Volume Pipette and Accessories

Manufacturer:

GUANGZHOU FOUR E'S SCIENTIFIC CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 7, 2023

iLONGCARE DS-300S Semi-auto Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN LONGCARE BIOTECH CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 4, 2023

KEMILO D-Dimer Kit and Accessories

Manufacturer:

GOLDSITE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2023

GOLDSITE Chemiluminescence Immunoassay Analyzer and Accessories

Manufacturer:

GOLDSITE DIAGNOSTIC, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 27, 2023

HRJ-BIO QC Solution

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

iLONGCARE iMagic - S7 Automatic Chemistry Analyzer

Manufacturer:

SHENZHEN LONGCARE BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

GOLDSITE Kemilo 25-OH-VD Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

HRJ-BIO Alpha Fetoprotein (AFP) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

GOLDSITE Kemilo NT-ProBNP Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2023

GOLDSITE Kemilo Tβ-HCG Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2023

iLONGCARE iChem-535 Semi-auto Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN LONGCARE BIOTECH CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 21, 2023

GOLDSITE Kemilo Myo Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

GOLDSITE Kemilo TSH Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

HRJ-BIO Cleaning Solution

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 29, 2022

MEDICALSYSTEM LYA-1 Automated Hematology Analyzer Lyse

Manufacturer:

MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2022

MEDICALSYSTEM LYA-3 Automated Hematology Analyzer Lyse

Manufacturer:

MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2022

HRJ-BIO E800 Electrolyte Analyzer

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

MEDICALSYSTEM LYA-2 Automated Hematology Analyzer Lyse

Manufacturer:

MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

MEDICALSYSTEM DIL-A Automated Hematology Analyzer Diluent

Manufacturer:

MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2022

WANTAI HEV-Ag ELISA Plus

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO.,LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 16, 2022

MEDICALSYSTEM LYC-1 Automated Hematology Analyzer Lyse

Manufacturer:

MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2022

MEDICALSYSTEM MS-H652 Automated Hematology Analyzer and Accessories

Manufacturer:

NINGBO MEDICALSYSTEM BIOTECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

HRJ-BIO Free Thyroxine (FT4) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

KEMILO cTnl Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

KEMILO Prog Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

MEDICALSYSTEM DIL-C Automated Hematology Analyzer Diluent

Manufacturer:

MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

MEDICALSYSTEM LYE-1 Automated Hematology Analyzer Lyse

Manufacturer:

MEDICALSYSTEM BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2022

ZENIX ZS-QC QC solution

Manufacturer:

GENRUI BIOTECH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

KEMILO CK-MB Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2022

KEMILO PCT Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2022

KEMILO T4 Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

KEMILO T3 Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2022

KEMILO FT4 Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

KEMILO FT3 Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

HRJ-BIO Free Triiodothyronine (FT3) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

HRJ-BIO Vitamin D (VD) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

HRJ-BIO Interleukin 6 (IL-6) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 27, 2022

KEMILO IL-6 Kit

Manufacturer:

GOLDSITE DIAGNOSTICS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 16, 2022

HRJ-BIO Triiodothyronine (T3) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2022

HRJ-BIO Creatinine (CREA) Reagent Kit (Sarcosine Oxidase Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

HRJ-BIO Aspartate Amino Transferase (AST) Reagent Kit (IFCC Kinetic Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

HRJ - BIO Creatinine (CREA) Reagent Kit (Sarcosine Oxidase Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

HRJ Biotech Cardiac Troponin I (cTnl) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 24, 2022

HRJ-BIO Triglyceride (TG) Reagent Kit (GPO-PAP Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

HRJ - BIO Uric Acid (UA) Reagent Kit (Uricase-Peroxidase Coupling Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

HRJ-BIO Cholesterol (CHOL) Reagent Kit (GOD-PAP Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

HRJ-BIO Glucose (GLU) Reagent Kit (Glucose Oxidase Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2022

HRJ-BIO Urea (UREA) Reagent Kit (Enzyme-coupling Kinetic Method) Method)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

HRJ BIO Myoglobin (Myo) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2022

D-Dimer Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2022

ZENIX ZN-390 Plus Microplate Washer

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 9, 2022

ZENIX-188 Semi-auto Chemistry Analyzer

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2022

ZENIX ZN-320 Microplate Reader

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2022

ZENIX ZN-390 Microplate Washer

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2022

ZENIX ZN-244 Full-auto Hematology Analyzer and Accessories

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2022

ZENIX ZN-144 Full-auto Hematology Analyzer and Accessories

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2022

Follicle Stimulating Hormone (FSH) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2022

HRJ BIO Thyroxine (T4) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2022

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2022

Creatine Kinase Isoenzyme-MB (CK-MB) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2022

Thyroid Stimulating Hormone (TSH) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2022

HRJ-BIO Procalcitonin (PCT) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2022

Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 23, 2022

High Sensitive C-Reactive Protein (hs-CRP) Test Kit (Immunofluorescence)

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

HRJ-BIO Quantitative Immunoassay Analyzer

Manufacturer:

HRJ BIOTECH MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 14, 2022

ICUBIO Glutamate Pyruvate Transaminase (ALT) Assay Kit

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2022

ICUBIO ALB Albumin Assay Kit (Bromocresol Green Method)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2022

ICUBIO DBil Direct Bilirubin Assay Kit (Vanadate Oxidation Method )

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2022

ICUBIO Urea Assay Kit (Enzymatic Method)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2022

ICUBIO Cre Creatinine Assay Kit (Enzymatic Method)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2022

iCubio Uric Acid - UA (Enzymatic Method)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 19, 2022

ICUBIO CHO Total Cholesterol Assay Kit

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2022

ICUBIO HDL-C Direct Hight Density Lipoprotein Cholesterol Assay Kit (Direct Method)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2022

ICUBIO TBil Total Bilirubin Assay Kit (Vanadate Oxidation Method)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2022

ICUBIO Glutamate Oxaloacetate Transaminase (AST) Assay Kit (IFCC Method)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2022

ICUBIO iMagic - S7 Automatic Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2022

ICUBIO TP Total Protein Assay Kit (Biuret Reaction Method)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2022

ICUBIO iChem 535 Semi-auto Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 13, 2022

ICUBIO GLU Glucose Assay Kit (Glucose Oxidase Method)

Manufacturer:

SHENZHEN ICUBIO BIOMEDICAL TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 12, 2022

WANTAI HBsAb Elisa Kit

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO. LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 17, 2021

ZENIX Alkaline Phosphatase Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

ZENIX Alanine Aminotransferase Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2021

ZENIX Total Protein Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2021

ZENIX Albumin Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2021

WANTAI HBsAg ELISA Kit

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 10, 2021

WANTAI SARS-CoV-2 RT-PCR Kit

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2021

WANTAI Anti-HCV ELISA Kit

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 12, 2021

WANTAI TB - IGRA ELISA Kit

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 10, 2021

WANTAI Anti-TP ELISA Kit

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRICE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 10, 2021

WANTAI HAV-IgM ELISA Kit

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 10, 2021

ZENIX Low Density Lipoprotein Cholesterol Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 10, 2021

WANTAI Anti-HIV (1+2) ELISA Kit

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 7, 2021

ZENIX Aspartate Aminotransferase Assay Reagent Kit (Aspartate Method)

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2021

ZENIX ZS-Ref Ref Filling Solution

Manufacturer:

GENRUI BIOTECH INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2021

ZENIX Direct Bilirubin Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2021

ZENIX Total Bilirubin Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2021

ZENIX High Density Lipoprotein Cholesterol Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2021

ZENIX Uric Acid Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2021

ZENIX Cholesterol Assay Reagenl Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2021

ZENIX Creatine Kinase Assay Reagent Kit (Creatinine Phosphate Method)

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2021

ZENIX Triglycerides Assay Reagent Kit (GPO-PAP Method)

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2021

ZENIX Urea Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2021

ZENIX Glucose Assay Reagent Kit

Manufacturer:

RAYTO LIFE AND ANALYTICAL SCIENCES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 11, 2021

AiD ™ anti-HCV Elisa Plus

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO.,LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 30, 2020

AiD HBsAg ELISA

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO.,LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 30, 2020

AiD™ HIV 1+2 Ag/Ab ELISA Plus

Manufacturer:

BEIJING WANTAI BIOLOGICAL PHARMACY ENTERPRISE CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 26, 2020

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

Last updated: December 2025