SD BIOSENSOR SARS-CoV-2 Rapid Antibody Test - Indonesia BPOM Medical Device Registration
SD BIOSENSOR SARS-CoV-2 Rapid Antibody Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303024930. The device is manufactured by SD BIOSENSOR from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ROCHE INDONESIA.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Risk Classification
Product Class
Kelas : 2
Manufacturer
SD BIOSENSORCountry of Origin
Korea
Authorized Representative
PT. ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Jun 03, 2021
Expiry Date
Jul 15, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
STANDARD M10 DENV 1-4
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STANDARD Lipidocare Analyzer (NB)
STANDARD F NT-proBNP FIA
STANDARDโข F hs-CRP
STANDARD M10 MTB/NTM
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