VAZYME Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - Indonesia BPOM Medical Device Registration

VAZYME Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303120690. The device is manufactured by NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HEALTHY FAMILY FOCUS.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

BPOM Registered

Risk Class Kelas Resiko : B

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

Analysis ID: AKL 20303120690

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Country of Origin

China

Authorized Representative

PT. HEALTHY FAMILY FOCUS

AR Address

Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9

Registration Date

Dec 14, 2022

Expiry Date

Oct 17, 2026

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Other Products from NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.

Products from the same manufacturer (10 products)

VAZYME Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) - Indonesia BPOM Medical Device Registration

Risk Classification

Product Class

Manufacturer

Country of Origin

Authorized Representative

AR Address

Registration Date

Expiry Date

Product Type

DJ Fang

VAZYME Fluorescence Immune Analyzer

VAZYME N-terminal pro B-type natriuretic peptide (NT-proBNP) Test Kit

Vazyme Myolobin (Mayo) Test Kit

VAZYME Quality Control (MYO)

VAZYME Quality Control (NT-proBNP)

VAZYME Quality Control (CK-MB)

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

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

VAZYME Quality Control (hs-cTnT)

VAZYME Quality Control (CRP)

AYOTES CLIA based Soluble Growth Stimulation Expressed Gene 2 Test Kit

AYOTES CLIA based Pepsinogen I (PGI) Test Kit

AYOTES CLIA based α - Fetoprotein Test Kit

AYOTES CLIA based Cytokeratin 19 Fragments Test Kit

AyoTes CLIA based Aldosteron Test Kit

AyoTes CLIA based Cortisol Test Kit

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

AyoTes CLIA based Testosterone Test Kit

AyoTes CLIA based Myoglobin (MYO) Test Kit

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