STANDARD F T4 - Indonesia BPOM Medical Device Registration
STANDARD F T4 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101221811. The device is manufactured by SD BIOSENSOR from Korea, 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 BIOSENSORCountry of Origin
Korea
Authorized Representative
STANDARD BIOSENSOR INDONESIAAR Address
L'Avenue Office Tower Lt.21 Unit C, Jl. Raya Pasar Minggu Kav.16 Kel. Pancoran Kec. Pancoran , Jakarta Selatan
Registration Date
Oct 24, 2022
Expiry Date
Dec 30, 2024
Product Type
Clinical Chemistry Test System
Thyroxine-binding globulin test system (kit & cair)
Invitro Diagnostics
STANDARD M10 DENV 1-4
STANDARD F TSH-II FIA
STANDARD Lipidocare Analyzer (NB)
STANDARD F NT-proBNP FIA
STANDARD™ F hs-CRP
STANDARD M10 MTB/NTM
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STANDARD Q Dengue Duo Test
STANDARD™ Q H pylori Ab Test
STANDARD Q H pylori Ag Test
VIASURE Monkeypox virus Real Time PCR Detection Kit 12 x 8-well strips
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VIASURE Zika, Dengue & Chikungunya Real Time PCR Detection Kit 12 x 8-well strips
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VIASURE Dengue Virus Real Time PCR Detection Kit
CERTEST BIOTEC S.L
VIASURE Sexually Transmitted Diseases Real Time PCR Detection Kit
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STANDARD F TnI FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F iFOB FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F TnI/CK-MB Combo FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F NT-proBNP FIA
SD BIOSENSOR
STANDARD F CK-MB FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.
STANDARD F D-dimer FIA
SD BIOSENSOR HEALTHCARE PVT. LTD.