Xpert MTB/XDR - Indonesia BPOM Medical Device Registration

Xpert MTB/XDR is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420598. The device is manufactured by CEPHEID AB from Sweden, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEDQUEST JAYA GLOBAL.

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BPOM Registered

Risk Class Kelas Resiko : B

Xpert MTB/XDR

Analysis ID: AKL 20303420598

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

CEPHEID AB

Country of Origin

Sweden

Authorized Representative

PT. MEDQUEST JAYA GLOBAL

AR Address

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

Registration Date

Nov 11, 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