ZYBIO D-Dimer Reagent Kit (Immunoturbidimetric Assays) - Indonesia BPOM Medical Device Registration
ZYBIO D-Dimer Reagent Kit (Immunoturbidimetric Assays) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207420047. The device is manufactured by SHENZHEN THISTORY BIO-MEDICAL CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. ZYBIO MEDICAL INDONESIA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SHENZHEN THISTORY BIO-MEDICAL CO., LTD.Country of Origin
China
Authorized Representative
PT. ZYBIO MEDICAL INDONESIAAR Address
Satrio Tower Unit 8, Lantai 14 No. 5 Bok C4, Jl. Prof. Dr, Satrio No. 7, Kel. Setiabudi, Kec. Kuningan Timur, Kota Jakarta Selatan, Prov. DKI Jakarta
Registration Date
Apr 30, 2024
Expiry Date
Jan 30, 2029
Product Type
Haematology Package and Kit
Fibrinogen/fibrin degradation products assay.
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