SD BIOSENSOR SARS-CoV-2 Antigen Control - Indonesia BPOM Medical Device Registration
SD BIOSENSOR SARS-CoV-2 Antigen Control is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303120352. The device is manufactured by SD BIOSENSOR from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ROCHE INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SD BIOSENSORCountry of Origin
Korea
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Nov 09, 2021
Expiry Date
Dec 07, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
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
Elecsys Anti-SARS-CoV-2 cobas e analyzers
ROCHE DIAGNOSTICS GMBH.
PreciControl Maternal Care
ROCHE DIAGNOSTICS GMBH
COAGUCHEK aPTT Test
ROCHE DIAGNOSTICS GMBH.
ROCHE TROP T Sensitive, Troponin T
ROCHE DIAGNOSTICS GMBH.
COBAS BM - Lactate
ROCHE DIAGNOSTICS GMBH.
ultraView Universal Alkaline Phosphatase Red Detection Kit
VENTANA MEDICAL SYSTEMS, INC.
COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Wash Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Lysis Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Specimen Diluent
ROCHE MOLECULAR SYSTEMS INC.