MTBDR-RIF 9G Membrane KIT™ - Indonesia BPOM Medical Device Registration

MTBDR-RIF 9G Membrane KIT™ is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220423. The device is manufactured by BIOMETRIC TECHNOLOGY, INC. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NEXT LEVEL MEDICAL.

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BPOM Registered

Risk Class Kelas Resiko : B

MTBDR-RIF 9G Membrane KIT™

Analysis ID: AKL 20303220423

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIOMETRIC TECHNOLOGY, INC.

Country of Origin

Korea

Authorized Representative

PT. NEXT LEVEL MEDICAL

AR Address

JALAN BUKIT GADING RAYA, KOMPLEK GADING BUKIT INDAH, BLOK TB KAVLING NO. 30 LT.3

Registration Date

Jul 06, 2022

Expiry Date

Feb 17, 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