BIOTIME cTnI/CK-MB/Myo Rapid Quantitative Test - Indonesia BPOM Medical Device Registration
BIOTIME cTnI/CK-MB/Myo Rapid Quantitative Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101026813. The device is manufactured by XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is INDOLAB ARTHA MEDIKA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
XIAMEN BIOTIME BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
INDOLAB ARTHA MEDIKAAR Address
Komp Ruko Sunter Paradise Tahap II Blok.A4 No.43. Sunter Agung Podomoro
Registration Date
Jun 21, 2022
Expiry Date
Oct 08, 2024
Product Type
Clinical Chemistry Test System
Creatine phosphokinase/creatine kinase or isoenzymes test system (card)
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