AMPLIRUN Total MDR-TB Verification and Control Panel (Sputum) - Indonesia BPOM Medical Device Registration

AMPLIRUN Total MDR-TB Verification and Control Panel (Sputum) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420012. The device is manufactured by VIRCELL S.L from Spain, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. NELTA MULTI GRACIA.

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BPOM Registered

Risk Class Kelas Resiko : C

AMPLIRUN Total MDR-TB Verification and Control Panel (Sputum)

Analysis ID: AKL 20303420012

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

VIRCELL S.L

Country of Origin

Spain

Authorized Representative

PT. NELTA MULTI GRACIA

AR Address

Metland Menteng. Jl. Menteng Niaga Blok J7 No.1 Ujung Menteng, Cakung, Jakarta Timur 13960

Registration Date

Jan 12, 2024

Expiry Date

Dec 31, 2026

Product Type

Serological Reagents

Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens (kit & cair)

Invitro Diagnostics