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PT. HEALTHY FAMILY FOCUS

Authorized Representative in Indonesia

Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9
126 Products Represented
18 Manufacturers
Total Products
126
Manufacturers
18
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
6 products
4.8%
Kelas Resiko : B
86 products
68.3%
Kelas Resiko : C
33 products
26.2%
Kelas Resiko : D
1 products
0.8%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (126)
Complete portfolio registered with BPOM

AYOTES CLIA based Soluble Growth Stimulation Expressed Gene 2 Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

AYOTES CLIA based Pepsinogen I (PGI) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

AYOTES CLIA based Cytokeratin 19 Fragments Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2025

AYOTES CLIA based α - Fetoprotein Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 1, 2025

AyoTes CLIA based Aldosteron Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

AyoTes CLIA based Cortisol Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

AyoTes CLIA based 25-hydroxy-vitamin D (25-OH VD) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 12, 2024

AyoTes CLIA based Testosterone Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 11, 2024

AyoTes CLIA based Myoglobin (MYO) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2024

AYOTES CLIA Based Creatine Kinase MB (CK-MB) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2024

AyoTes CLIA based Golgi protein 73 Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 3, 2024

AYOTES CLIA based Ferritin (Ferr) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2024

AyoTes CLIA based Cancer Antigen 242 Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 2, 2024

AyoTes Phenylalanine (Phe) Kit (Fluorescence Assay)

Manufacturer:

GUANGZHOU FENGHUA BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

AyoTes CLIA Based Human Epididymis protein 4 Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2024

AyoTes CLIA based Cancer Antigen 15-3 Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2024

AyoTes CLIA based Carcinoembryonic antigen (CEA) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2024

AyoTes CLIA based Cancer Antigen 125 Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2024

AyoTes Multifunctional Fluorescence Analyzer

Manufacturer:

GUANGZHOU FENGHUA BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2024

AyoTes HPLC HbA1c Test Reagent Kit

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2024

AyoTes HPLC HbA1c Test Reagent Kit (Variant Mode)

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2024

AyoTes CLIA Based Progesterone Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2024

AyoTes CLIA Based Prolactin Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2024

AyoTes HPLC HbA1c Control Kit

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2024

AyoTes HPLC HbA1c Calibrator Kit

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2024

AyoTes Dengue IgG/IgM Rapid Test Kit (Whole Blood/Plasma/Serum)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2024

AyoTes CLIA Based Follicle-stimulating Hormone (FSH) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

AyoTes CLIA Based Luteinizing Hormone Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

AYOTES CLIA Based β -Human Chorionic Gonadotropin Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

iSIA FT4 Rapid Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

AYOTES CLIA Based Estradiol Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

AYOTES Fully Automated HPLC Analyzer

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2024

iSIA Total Triiodothyronine (TT3) Rapid Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

AYOTES CLIA Based Anti-Mullerian Hormone (AMH) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

AyoTes Multifunctional Fluorescence Analyzer

Manufacturer:

GUANGZHOU FENGHUA BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 8, 2024

AyoTes Automatic Fluorescence Immunoassay Analyzer

Manufacturer:

GUANGZHOU FENGHUA BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

AyoTes Automatic Fluorescence Immunoassay Analyzer

Manufacturer:

GUANGZHOU FENGHUA BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 30, 2024

AyoTes G6PD Kit (Fluorescence Assay)

Manufacturer:

GUANGZHOU FENGHUA BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

AyoTes Neonatal TSH Kit (TRFIA)

Manufacturer:

GUANGZHOU FENGHUA BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

AyoTes Neonatal 17 α -OH Progesterone Kit (TRFIA)

Manufacturer:

GUANGZHOU FENGHUA BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

fT3 Rapid Test Kit (QDs Immunofluorescent Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

AyoTes Auto Chemiluminescence Immunoassay (CLIA) Analyzer

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

AyoTes CLIA Based N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

AyoTes HbsAg Rapid Test (Whole Blood/Serum/Plasma)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 6, 2024

AyoTes CLIA Based Thyroglobulin Antibody Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

AyoTes Gonorrhea Rapid Test (Swab)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

AyoTes CLIA Based Antithyroid Peroxidase Autoantibody Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2024

AyoTes Glycosylated Hemoglobin Hemolytic Agent

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 18, 2024

AyoTes CLIA Based Procalcitonin (PCT) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

AyoTes CLIA Based Intact Parathyroid Hormone (PTH) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 18, 2024

AyoTes CLIA Based Neutrophil Gelatinase-associated Lipocalin (NGAL) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 16, 2024

AyoTes CLIA Based Interleukin-6 (IL-6) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2024

AyoTes CLIA Based D-Dimer Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 4, 2024

AyoTes CLIA Based C-reactive Protein (CRP) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2024

AyoTes CLIA Based Thyroxine (T4) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2024

AyoTes CLIA Based Triiodothyronine (T3) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2024

AyoTes QD Based 25 Hydroxy vitamin D (25-OH VD) Test Kit

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2024

AyoTes QD Based Helicobacter pylori (HP typing: Cag A+ VacA+ Ure) Test Kit

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 29, 2024

AyoTes CLIA Based Glycosylated Hemoglobin (HbA1c) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 26, 2024

AyoTes CLIA based High Sensitive Cardiac Troponin-I (hs-cTnI) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

AyoTes CLIA based Thyroid-stimulating Hormone (TSH) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

AyoTes QD Based Procalcitonin (PCT) Test Kit

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

AyoTes CLIA based Free Triiodothyronine (FT3) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

AyoTes CLIA based Free Tyroxine (FT4) Test Kit

Manufacturer:

BEIJING HOTGEN BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

AyoTes QD Based Troponin I (cTnI) Test Kit

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

AyoTes QD Based C-reactive Protein (CRP+hs-CRP) Test Kit

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2024

Vazyme Myolobin (Mayo) Test Kit

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 4, 2024

iSIA Fluorescent Immuno Analyzer and Accessories

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

HOB BioCLIA Autoimmune Reagent Kit

Manufacturer:

HOB BIOTECH GROUP CORP., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

AyoTes Quantum Dot Fluorescent Immuno Analyzer

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2023

AyoTes Chlamydia Rapid Test (Secretion)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2023

AyoTes Methamphetamine (MET) Rapid Test (Urine)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

AyoTes Tetrahydrocannabinol (THC) Rapid Test (Urine)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

SAVVYCHECK Vaginal Yeast Infection Test (OTC)

Manufacturer:

SAVYON DIAGNOSTICS, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2023

AyoTes Multi Drug 7 Panel Test (AMP/THC/MOP/MET/BZO/COC/SOMA) (Urine)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2023

AyoTes Multi Drug 7 Panel Test (AMP/THC/MOP/MET/BZO/COC/K2) (Urine)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2023

AyoTes Amphetamine (AMP) Rapid Test (Urine)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

AyoTes QD Based Glycosylated Hemoglobin (HbA1c)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

VAZYME High Sensitivity Cardiac Troponin T (hs-cTnT) Test Kit

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2023

iSIA Osteocalcin Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

iSIA Whole Parathyroid Hormone Rapid Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

iSIA Serum Amyloid A (SAA)/ C-reactive protein (CRP+hs-CRP) Combined Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

iSIA Creatine kinase isoenzyme (CK-MB) Rapid Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2023

iSIA Vascular Endothelial Growth Factor Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

ISIA Ferritin Rapid Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

iSIA Anti-Mullerian Hormone Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

iSIA Myoglobin (MYO) Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2023

iSIA Heart fatty acid-binding protein Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2023

iSIA Gastrin-17 Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2023

iSIA 25 Hydroxy vitamin D Rapid Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2023

iSIA Interleukin 6 (IL-6)/Procalcitonin (PCT) Combined Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 4, 2023

AyoTes Dengue IgG/IgM&NS1 Rapid Test (Whole Blood/Serum/Plasma)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2023

iSIA Helicobacter pylori (H. pylori) Typing Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2023

iSIA C-reactive protein (CRP+hs-CRP) Rapid Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

AyoTes Dengue NS1 Antigen Rapid Test (Whole Blood/Serum/Plasma)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2023

iSIA Troponin I Rapid Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

AyoTes Multi Drug 5 Panel Test (AMP/THC/MOP/MET/BZO) (Urine)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 28, 2023

AyoTes Typhoid IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

iSIA Procalcitonin Rapid Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

AyoTes Multi Drug 6 Panel Test (AMP/THC/MOP/MET/BZO/COC) (Urine)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2023

AyoTes Multi Drug 3 Panel Test (AMP/THC/MOP) (Urine)

Manufacturer:

ASSURE TECH. (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2023

VAZYME Quality Control (PCT/IL6)

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2023

iSIA Glycosylated Hemoglobin Test Kit (QDs Immunofluorescence Method)

Manufacturer:

CHONGQING ISIA BIO-TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2023

VAZYME Disposable Virus Sampling Tube (Non-Inactivated)

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 1, 2023

AyoTes Hematology Reagent - Diluent

Manufacturer:

WHEISMAN MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

AyoTes Hematology Reagent - Probe Cleanser W-5P

Manufacturer:

WHEISMAN MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 10, 2023

AyoTes Hematology Reagent - Lyse

Manufacturer:

WHEISMAN MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2023

AyoTes Hematology Reagent - Lyse W-61LH

Manufacturer:

WHEISMAN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

AyoTes HbA1c Calibrator

Manufacturer:

SHENZHEN LIFOTRONIC TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

AyoTes HbA1c Reagent Kit (HPLC)

Manufacturer:

SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

AyoTes Auto Hematology Analyzer

Manufacturer:

WHEISMAN MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

AyoTes Hemoglobin Analyzer (HPLC)

Manufacturer:

SHENZEN LIFOTRONIC TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

AyoTes HbA1c Control Material

Manufacturer:

SHENZHEN LIFOTRONIC TECHNOLOGY CO., LTD, CHINA

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

VAZYME Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

VAZYME High Sensitivity Cardiac Troponin I (hs-cTnl) Test Kit (Quantum Dots Fluorescence Immunochromatography)

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2022

VAZYME Brain Natriuretic Peptide (BNP) Test Kit (Quantum Dots Fluorescence Immunochromatography)

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 18, 2022

VAZYME D-Dimer Test Kit (Quantum Dots Fluorescence Immunochromatography)

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 14, 2022

VAZYME Interleukin 6 (IL-6) Test Kit (Quantum Dots Fluorescence Immunochromatography)

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2022

VAZYME Procalcitonin (PCT) Test Kit (Quantum Dots Fluorescence Immunochromatography)

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2022

VAZYME Full-Scale C-Reactive Protein (CRP) Test Kit (Quantum Dots Fluorescence Immunochromatography)

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2022

VAZYME Automatic Flourescence Immunoassay Analyzer

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 25, 2022

VAZYME DNA/RNA Extraction Kit

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 22, 2021

VAZYME FastPure Viral DNA/RNA Mini Kit

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 21, 2021

VAZYME Virus Sample Stabilizer

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 21, 2021

VAZYME Quantum Dot Fluorescence Immune Analyzer

Manufacturer:

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

Vazyme Real-Time Quantitative Thermal Cycler

Manufacturer:

SUZHOU MOLARRAY BIOLOGICAL TECHNOLOGY CO.LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 1, 2021

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

Last updated: December 2025