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COBAS HBV Quantitative nucleic acid test for use on the cobas 6800/8800 Systems - Indonesia BPOM Medical Device Registration

COBAS HBV Quantitative nucleic acid test for use on the cobas 6800/8800 Systems is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305024167. 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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BPOM Registered
Risk Class Kelas Resiko : D
COBAS HBV Quantitative nucleic acid test for use on the cobas 6800/8800 Systems
Analysis ID: AKL 30305024167

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

United States

Authorized Representative

PT. ROCHE INDONESIA

AR Address

Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi

Registration Date

Jul 03, 2020

Expiry Date

Feb 27, 2025

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

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