STANDARD M10 MDR-TB - Indonesia BPOM Medical Device Registration
STANDARD M10 MDR-TB is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420273. The device is manufactured by SD BIOSENSOR from Korea, and is classified as Risk Class Kelas Resiko : C. 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 BUILDING UNIT C, LT. 21, JL. RAYA PASAR MINGGU KAV. 16
Registration Date
Jun 28, 2024
Expiry Date
Jan 18, 2029
Product Type
Serological Reagents
Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens (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
SD BIOSENSOR TB-Feron SPP
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
CERTEST BIOTEC S.L
VIASURE Zika, Dengue & Chikungunya Real Time PCR Detection Kit 12 x 8-well strips
CERTEST BIOTEC S.L
VIASURE Dengue Virus Real Time PCR Detection Kit
CERTEST BIOTEC S.L
VIASURE Sexually Transmitted Diseases Real Time PCR Detection Kit
CERTEST BIOTEC S.L
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.