VAZYME High Sensitivity Cardiac Troponin I (hs-cTnl) Test Kit (Quantum Dots Fluorescence Immunochromatography) - Indonesia BPOM Medical Device Registration
VAZYME High Sensitivity Cardiac Troponin I (hs-cTnl) Test Kit (Quantum Dots Fluorescence Immunochromatography) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101222038. The device is manufactured by NANJING VAZYME MEDICAL TECHNOLOGY.,LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. HEALTHY FAMILY FOCUS.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
NANJING VAZYME MEDICAL TECHNOLOGY.,LTDCountry of Origin
China
Authorized Representative
PT. HEALTHY FAMILY FOCUSAR Address
Komplek Delta Building Blok B 1-2, Jalan Suryopranoto No. 1-9
Registration Date
Nov 21, 2022
Expiry Date
Mar 08, 2027
Product Type
Clinical Chemistry Test System
Creatine phosphokinase/creatine kinase or isoenzymes test system (card)
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