COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 - Indonesia BPOM Medical Device Registration
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305024719. The device is manufactured by ROCHE MOLECULAR SYSTEMS INC. from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. ROCHE INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
ROCHE MOLECULAR SYSTEMS INC.Country of Origin
United States
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
Jul 24, 2020
Expiry Date
Feb 27, 2025
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
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