COBAS CalSet Anti-SARS-CoV-2 S cobas e analyzers - Indonesia BPOM Medical Device Registration
COBAS CalSet Anti-SARS-CoV-2 S cobas e analyzers is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303027486. The device is manufactured by ROCHE DIAGNOSTICS GMBH from Germany, 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
ROCHE DIAGNOSTICS GMBHCountry of Origin
Germany
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Aug 13, 2021
Expiry Date
Sep 23, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
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