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PT. ZYBIO MEDICAL INDONESIA

Authorized Representative in Indonesia

Satrio Tower Unit 8, Lantai 14 No. 5 Bok C4, Jl. Prof. Dr, Satrio No. 7, Kel. Setiabudi, Kec. Kuningan Timur, Kota Jakarta Selatan, Prov. DKI Jakarta
188 Products Represented
5 Manufacturers
Total Products
188
Manufacturers
5
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
17 products
9.0%
Kelas Resiko : B
142 products
75.5%
Kelas Resiko : C
28 products
14.9%
Kelas Resiko : D
1 products
0.5%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (188)
Complete portfolio registered with BPOM

ZYBIO FT4 Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 13, 2025

ZYBIO Urinalysis Hybrid System Series U3601

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2024

ZYBIO H58 LD Lyse

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

ZYBIO H58 DR Diluent

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2024

ZYBIO H58 FN Dye

Manufacturer:

ZYBIO INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 18, 2024

ZYBIO H58 FR Dye

Manufacturer:

ZYBIO INC.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 16, 2024

Zybio Automated Blood Coagulation Analyzer YX-3000

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 2, 2024

Zybio Automated Blood Coagulation Analyzer YX-2000

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

Zybio Antithrombin III Reagent Kit (Chromogenic Substrate Method)

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

Zybio Blood Coagulation Unassayed Controls

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2024

ZYBIO Substrate

Manufacturer:

ZYBIO INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 11, 2024

Zybio Hematology Control H5 Check (Low Level)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

ZYBIO Hematology Control H5 Check (High Level)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

ZYBIO Hematology Control H5 Check (Normal Level)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2024

ZYBIO Probe Cleanser

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 27, 2024

ZYBIO Human Papillomavirus qPCR Detection Kit (PCRFluorescence Probing Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2024

ZYBIO C-Reactive Protein/Serum Amyloid A Control

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

ZYBIO Fibrinogen Reagent Kit (Clotting Method)

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

ZYBIO Activated Partial Thromboplastin Time Reagent Kit (Clotting Method)

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

ZYBIO Thrombin Time Reagent Kit (Clotting Method)

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

ZYBIO Prothrombin Time Reagent Kit (Clotting Method)

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

ZYBIO D-Dimer Controls

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 2, 2024

ZYBIO FDP Reagent Kit (Immunoturbidimetric Assays)

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

ZYBIO D-Dimer Reagent Kit (Immunoturbidimetric Assays)

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

ZYBIO Fibrin/fibrinogen degradation products Controls

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 30, 2024

ZYBIO Diluent Buffer

Manufacturer:

SHENZHEN THISTORY BIO-MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 5, 2024

ZYBIO Calcium (Ca) Kit (Arsenazo III Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

ZYBIO Creatine Kinase MB Isoenzyme (CK-MB) Kit (Immunoinhibition Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2024

ZYBIO Albumin (ALB) Kit (Bromocresol Green Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2023

ZYBIO Total Protein (TP) Kit (Biuret Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

ZYBIO Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

ZYBIO Lactate Dehydrogenase (LDH) Kit (Rate Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

ZYBIO Aspartate Aminotransferase (AST) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

ZYBIO Triglyceride (TG) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

ZYBIO Alkaline Phosphatase (ALP) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2023

ZYBIO Gamma-Glutamyl Transferase (GGT) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2023

ZYBIO Urea (UREA) Kit (Urease-GLDH Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2023

ZYBIO Alanine Aminotransferase (ALT) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2023

ZYBIO Uric Acid (UA) Kit (Uricase Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2023

ZYBIO Total Bilirubin (TBIL) Kit (Vanadate Oxidation Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 18, 2023

Zybio Chemiluminescence Immunoassay Analyzer EXI 1820

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2023

ZYBIO Lyse (LP)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

ZYBIO Hematology Analyzer EXZ 6010 Pro

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

ZYBIO Check-P Control

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2023

Zybio Hematology Analyzer Model EXZ 6000 Pro

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2023

ZYBIO Cal-P Calibrator

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2023

Zybio Serum Amyloid A Protein Kit (Immunoassay)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

Zybio C-Reactive Protein Kit (Immunoassay)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

ZYBIO α-Amylase (α-AMY) Kit (E-pNP-G7 Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 16, 2023

Zybio Ultra Fast Real-time PCR System Model EXP 160R

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 17, 2023

ZYBIO Hematology Control H3 Check (Low Level)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

ZYBIO Hematology Control H3 Check (High Level)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 17, 2023

ZYBIO Clinical Chemistry Multi-analyte Calibrator

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2023

ZYBIO Creatine Kinase MB Isoenzyme (CK-MB) Kit (Immunoinhibition Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2023

MOLACCU COVID-19 Detection Kit

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2023

ZYBIO SARS-CoV-2 Nucleic Acid Detection Kit (PCR Fluorescent Probe Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2023

ZYBIO SARS-CoV-2 Antigen Assay Kit (Colloidal Gold Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2023

ZYBIO Molaccu Fast SARS-CoV-2 RT-qPCR Detection Kit (PCR-Fluorescent Probe Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2023

ZYBIO Z5-LB Lyse

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2023

ZYBIO PCT Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 16, 2023

ZYBIO Troponin T/CK-MB/Myoglobin Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 16, 2023

ZYBIO TSH Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 14, 2023

Zybio T4 Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ZYBIO T3 Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ZYBIO Magnesium (Mg) Kit (Xylidyl Blue Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

NT-proBNP Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 6, 2023

Serum Amyloid A Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

ZYBIO Interleukin-6 Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 4, 2023

ZYBIO Total Cholesterol (CHOL) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

ZYBIO Alanine Aminotransferase (ALT) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

ZYBIO Lipase (LPS) Kit (Colorimetric Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

ZYBIO Troponin T Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2023

ZYBIO D-Dimer Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 26, 2023

ZYBIO Uric Acid (UA) Kit (Uricase Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

ZYBIO Low Density Lipoprotein Cholesterol (LDL-C) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

ZYBIO C-Reactive Protein Kit (Immunoturbidimetric method)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

ZYBIO Glycosylated Hemoglobin A1c Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

ZYBIO Glucose (GLU) Kit (Hexokinase Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2023

Zybio Lactate Dehydrogenase (LDH) Kit (Rate Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2023

Zybio Aspartate Aminotransferase (AST) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2023

ZYBIO Triglyceride (TG) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2023

ZYBIO Nucleic Acid Extraction Kit for Virus (Magnetic Bead Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 17, 2023

ZYBIO Hematology Control H3 Check

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2023

ZYBIO Hematology Calibrator (CAL)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2023

ZYBIO High Density Lipoprotein Cholesterol (HDL-C) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

ZYBIO cTnI Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2023

Zybio EXZ 6010 Hematology Analyzer

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

Zybio Lyse (H56, LD-I)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

ZYBIO EXZ 6020 Hematology Analyzer and Accessories

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ZYBIO EXZ 6000 Hematology Analyzer

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ZYBIO Lyse (H56 LD-II)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2023

ZYBIO Creatinine (CREA) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2023

Zybio Fluoroscence Immunochromatography Analyzer Model EXR 120

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2023

ZYBIO Fluoroscence Immunochromatography Analyzer EXR 110

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2023

ZYBIO Fluoroscence Immunochromatography Analyzer Model EXR 100

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

Zybio Nucleic Acid Extraction Kit for Bacteria (Magnetic Bead Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 1, 2023

Zybio Nucleic Acid Extraction Kit for FFPE (Magnetic Bead Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 26, 2023

Zybio Nucleic Acid Extraction Kit for Stool (Magnetic Bead Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 23, 2023

Zybio Urinalysis Diluent

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 17, 2023

ZYBIO Turbidity Control

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ZYBIO UDC Control

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ZYBIO SG Control

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ZYBIO Focusing Fluid

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ZYBIO Urinalysis Strip (Dry Chemistry Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

ZYBIO US Calibrator

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ZYBIO Urine Sediment Analyzer U2610

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ZYBIO Z50 Hematology Analyzer and Accessories

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ZYBIO Z52 Hematology Analyzer and Accesories

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ZYBIO Conductivity Calibrator

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Zybio Color Control

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ZYBIO Conductivity Control

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ZYBIO Urine Sediment Analyzer U2600

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

Zybio Urine Chemistry System U1600

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

Zybio Urinalysis Chemistry System U1602

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

Zybio Urinalysis Hybrid System Seri U3602

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2022

ZYBIO Alkaline Phospatase (ALP) Kit (Enzymatic Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

ZYBIO Total Protein (TP) Kit (Biuret Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2022

Zybio Hepatitis B Virus Nucleic Acid Quantitative Detection Kit (PCR-Fluorescent Probe Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 21, 2022

ZYBIO Urea Kit (Urease-GLDH Method)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

ZYBIO Albumin (ALB) Kit (Bromocresol Green Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

Zybio Total Bilirubin (TBIL) Kit (Vanadate Oxidation Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2022

ZYBIO Direct Bilirubin (DBIL) Kit (Vanadate Oxidation Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2022

ZYBIO Nucleic Acid Isolation System EXM 3000

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2022

ZYBIO Nucleic Acid Isolation System EXM 6000

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2022

ZYBIO SARS-CoV-2 Antibody Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2022

ZYBIO Nucleic Acid Extraction Kit for Virus (Magnetic Bead Method)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 30, 2022

ZYBIO Nucleic Acid Extraction Kit for Whole Blood (Magnetic Bead Method)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 30, 2022

ZYBIO NSE Assay (CLIA)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2022

ZYBIO ProGRP Assay (CLIA)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

ZYBIO Testosterone Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

ZYBIO PCT Assay (CLIA)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

ZYBIO β-HCG Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

Zybio FSH Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 26, 2022

Zybio PRL Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

Zybio Pepsinogen I (PG I) Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

Zybio Pepsinogen II (PG II) Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 18, 2022

ZYBIO Ferritin Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2022

ZYBIO Anti-TPO Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2022

ZYBIO HE4 Assay (CLIA)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2022

ZYBIO Gastrin-17 Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2022

ZYBIO CA 72-4 Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 6, 2022

ZYBIO E2 Assay (CLIA)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 3, 2022

ZYBIO CA 242 Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 3, 2022

ZYBIO Anti-TG Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

ZYBIO LH Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

ZYBIO Progesterone Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

Z3 Hematology Analyzer And Accessories

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

ZYBIO EXS 2000 Mass Spectrometry System

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

ZYBIO CA 50 Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 28, 2022

ZYBIO CA 15-3 Assay (CLIA)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 26, 2022

ZYBIO AMH Assay (CLIA)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2022

ZYBIO cTnI Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2022

ZYBIO FT4 Assay (CLIA)

Manufacturer:

ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2022

Zybio FT3 Assay (CLIA)

Manufacturer:

PT ZYBIO INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2022

ZYBIO T4 Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2022

ZYBIO AFP Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2022

ZYBIO T3 Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2022

ZYBIO CA19-9 Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2022

ZYBIO 25-hydroxyvitamin D Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2022

ZYBIO CEA Assay

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 16, 2022

ZYBIO TSH Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

ZYBIO Microbiology Calibrator

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

ZYBIO Chemistry Analyzer EXC200

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2022

ZYBIO C-Peptide Assay (CLIA)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2022

ZYBIO Chemistry Analyzer EXC400 and Accessories

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

ZYBIO Z5-LD Lyse

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

ZYBIO Lyse

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

Diluent

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

ZYBIO TG Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

ZYBIO Z5-DN Diluent

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

ZYBIO Z5 Hematology Analyzer And Accessories

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2022

ZYBIO Insulin Assay (CLIA)

Manufacturer:

ZYBIO INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

ZYBIO IL-6 Assay (CLIA)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2022

ZYBIO Sample Diluent

Manufacturer:

ZYBIO INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 23, 2022

ZYBIO Wash Buffer

Manufacturer:

ZYBIO INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 15, 2022

ZYBIO CA125 Assay

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2022

ZYBIO EXI1800 Chemiluminescence Immunoassay Analyzer

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ZYBIO Mold Sample Pretreatment Kit

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

ZYBIO Sample Treatment Matrix Solution

Manufacturer:

ZYBIO INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 28, 2022

ZYBIO Blood Culture Positive Sample Pretreatment Kit

Manufacturer:

ZYBIO INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 22, 2022

Mass Spectrometry System EXS2600

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2022

Microbe Sample Pretreatment Kit

Manufacturer:

ZYBIO INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 17, 2022

ZYBIO Chemistry Analyzer EXC420

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2022

Chemistry Analyzer EXC220

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2022

Fast Real-Time PCR System EXP 160

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 28, 2022

C-Reactive Protein Assay (Immunofluorescence)

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2022

Fluorescence Immunoassay Analyzer Q8 Pro

Manufacturer:

ZYBIO INC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 14, 2022

ZYBIO Disposable Virus Sampling Tube

Manufacturer:

ZYBIO INC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 6, 2022

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

Last updated: December 2025