BIOSCIENCE D-Dimer quantitative diagnostic kit (Time-Resolved Fluorescence Immunoassay) - Indonesia BPOM Medical Device Registration
BIOSCIENCE D-Dimer quantitative diagnostic kit (Time-Resolved Fluorescence Immunoassay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207122234. The device is manufactured by BIOSCIENCE (TIANJIN) DIAGNOSTIC TECHNOLOGY CO.,LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. PRATAMINDO MITRA RIZKY.
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Risk Classification
Product Class
Kelas : 2
Country of Origin
China
Authorized Representative
PT. PRATAMINDO MITRA RIZKYAR Address
Perumahan Bogorami Indah Regency, Jl. Bulak Setro Indah II Blok B 51-52, Surabaya
Registration Date
Apr 19, 2021
Expiry Date
Dec 30, 2024
Product Type
Haematology Package and Kit
Fibrinogen/fibrin degradation products assay.
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