STANDARD F TnI/CK-MB Combo FIA - Indonesia BPOM Medical Device Registration
STANDARD F TnI/CK-MB Combo FIA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101421830. The device is manufactured by SD BIOSENSOR HEALTHCARE PVT. LTD. from India, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is STANDARD BIOSENSOR INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SD BIOSENSOR HEALTHCARE PVT. LTD.Country of Origin
India
Authorized Representative
STANDARD BIOSENSOR INDONESIAAR Address
L'AVENUE BUILDING UNIT C, LT. 21, JL. RAYA PASAR MINGGU KAV. 16
Registration Date
Sep 19, 2024
Expiry Date
Jan 18, 2029
Product Type
Clinical Chemistry Test System
Creatine phosphokinase/creatine kinase or isoenzymes test system (card)
Invitro Diagnostics
STANDARD F TnI FIA
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STANDARD F CK-MB FIA
STANDARD F D-dimer FIA
STANDARD F T3
STANDARD F LH FIA
STANDARD F fT4
STANDARD F B-hCG FIA
STANDARD F T4
STANDARD F TSH FIA
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STANDARD F TnI FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F iFOB FIA
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STANDARD F CK-MB FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F D-dimer FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F T3
SD BIOSENSOR HEALTHCARE PVT. LTD.