COBAS EGFR Mutation Test v2 (EGFR V2) - Indonesia BPOM Medical Device Registration
COBAS EGFR Mutation Test v2 (EGFR V2) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305710224. The device is manufactured by ROCHE MOLECULAR SYSTEMS, INC. from United States, 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 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
Jun 21, 2021
Expiry Date
Apr 15, 2026
Product Type
Immunological Test System
Antinuclear antibody immunological test system.
Invitro Diagnostics
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