FASTPROBE Human HER2 Gene Amplification Detection Kit - Indonesia BPOM Medical Device Registration
FASTPROBE Human HER2 Gene Amplification Detection Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306420210. The device is manufactured by WUHAN HEALTHCARE BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BIOGEN SCIENTIFIC.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
WUHAN HEALTHCARE BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. BIOGEN SCIENTIFICAR Address
Rukan Tanjung Mas Raya Jl.Raya Lenteng Agung Blok B1 No.21 RT.002/RW.001 Tanjung Barat, Jagakarsa, Jakarta Selatan, DKI Jakarta
Registration Date
Oct 18, 2024
Expiry Date
Dec 31, 2029
Product Type
Tumor Antigen Immunologic Test System
Her2/Neu Gene Nucleic Acid Amplification for Breast Cancer using Chromogenic In Situ Hybridisation
Invitro Diagnostics
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