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ARGENE SARS-COV-2 R-GENE SPINNER - Indonesia BPOM Medical Device Registration

ARGENE SARS-COV-2 R-GENE SPINNER is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321254. The device is manufactured by BIOMERIEUX SA, (LOUIS PASTEUR) from France, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENSEVAL MEDIKA PRIMA.

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BPOM Registered
Risk Class Kelas Resiko : B
ARGENE SARS-COV-2 R-GENE SPINNER

ARGENE SARS-COV-2 RESPI R-GENE

Analysis ID: AKL 20303321254

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

France

Authorized Representative

PT. ENSEVAL MEDIKA PRIMA

AR Address

JL. PULO LENTUT NO.12, LT.1 UNIT 1C & LT.2 UNIT 2A, KAWASAN INDUSTRI PULOGADUNG

Registration Date

Jul 11, 2023

Expiry Date

Dec 31, 2026

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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