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COBAS Strep A Nucleic acid test for use on the cobas Liat System - Indonesia BPOM Medical Device Registration

COBAS Strep A Nucleic acid test for use on the cobas Liat System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303023156. 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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BPOM Registered
Risk Class Kelas Resiko : B
COBAS Strep A Nucleic acid test for use on the cobas Liat System
Analysis ID: AKL 20303023156

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

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

Nov 28, 2024

Expiry Date

Jul 16, 2029

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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