COBAS Elecsys AFP cobas e analyzers - Indonesia BPOM Medical Device Registration
COBAS Elecsys AFP cobas e analyzers is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306712015. 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 PT. ROCHE INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ROCHE DIAGNOSTICS GMBH.Country of Origin
Germany
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 17, 2021
Expiry Date
Apr 29, 2026
Product Type
Tumor Antigen Immunologic Test System
AFP-L3% immunological test system.
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