BD MAX™ MDR-TB - Indonesia BPOM Medical Device Registration

BD MAX™ MDR-TB is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420667. The device is manufactured by GENEOHM SCIENCES CANADA INC. from Canada, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BECTON DICKINSON INDONESIA.

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BPOM Registered

Risk Class Kelas Resiko : C

BD MAX™ MDR-TB

Analysis ID: AKL 20303420667

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

GENEOHM SCIENCES CANADA INC.

Country of Origin

Canada

Authorized Representative

PT. BECTON DICKINSON INDONESIA

AR Address

Sampoerna Strategic Square South Tower 20th Floor Jl. Jend. Sudirman Kav 45-46

Registration Date

Jan 20, 2025

Expiry Date

Dec 21, 2028

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