GENOSCHOLAR PZA-TB II - Indonesia BPOM Medical Device Registration
GENOSCHOLAR PZA-TB II is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303124038. The device is manufactured by KESTREL BIO SCIENCES THAILAND CO., LTD. from Thailand, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. UBC MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
KESTREL BIO SCIENCES THAILAND CO., LTD.Country of Origin
Thailand
Authorized Representative
PT. UBC MEDICAL INDONESIAAR Address
Jalan Rawa Gelam V, Blok L Kav. 11-13, Kawasan Industri Pulogadung Jakarta Timur13930
Registration Date
Jul 10, 2021
Expiry Date
Jun 15, 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)
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