VAZYME Procalcitonin (PCT) Test Kit (Quantum Dots Fluorescence Immunochromatography) - Indonesia BPOM Medical Device Registration
VAZYME Procalcitonin (PCT) Test Kit (Quantum Dots Fluorescence Immunochromatography) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220339. 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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
NANJING VAZYME MEDICAL TECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. HEALTHY FAMILY FOCUSAR Address
Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9
Registration Date
Jun 03, 2022
Expiry Date
Mar 08, 2027
Product Type
Serological Reagents
Procalcitonin test system
Invitro Diagnostics
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
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA based Pepsinogen I (PGI) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA based ฮฑ - Fetoprotein Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA based Cytokeratin 19 Fragments Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Aldosteron Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Cortisol Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based 25-hydroxy-vitamin D (25-OH VD) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Testosterone Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AyoTes CLIA based Myoglobin (MYO) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.
AYOTES CLIA Based Creatine Kinase MB (CK-MB) Test Kit
BEIJING HOTGEN BIOTECH CO., LTD.

