InnowaveDX IP-10.TB Mycobacterium Tubercullosis Spesific Effector Cell Immune Response Detection Kit (PCR-Fluorescence Probe Method) - Indonesia BPOM Medical Device Registration
InnowaveDX IP-10.TB Mycobacterium Tubercullosis Spesific Effector Cell Immune Response Detection Kit (PCR-Fluorescence Probe Method) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303420651. The device is manufactured by INNOWAVEDX (SUZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DARMA LABORA INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
INNOWAVEDX (SUZHOU) CO., LTD.Country of Origin
China
Authorized Representative
PT. DARMA LABORA INDONESIAAR Address
KAWASAN INDUSTRI JABABEKA 7, BLOK B3/B, DESA WANGUNHARJA
Registration Date
Dec 17, 2024
Expiry Date
Dec 31, 2026
Product Type
Serological Reagents
Nucleic acid-based in vitro diagnostics devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens (kit & cair)
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