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XPERT MTB/RIF Ultra - Indonesia BPOM Medical Device Registration

XPERT MTB/RIF Ultra is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420493. The device is manufactured by CEPHEID from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MEDQUEST JAYA GLOBAL.

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BPOM Registered
Risk Class Kelas Resiko : C
XPERT MTB/RIF Ultra
Analysis ID: AKL 20303420493

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

CEPHEID

Country of Origin

United States

Authorized Representative

PT. MEDQUEST JAYA GLOBAL

AR Address

MENARA SALEMBA LT.6 ZONE 1, Jalan SALEMBA RAYA KAV.5-5A

Registration Date

Oct 08, 2024

Expiry Date

Dec 31, 2025

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

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