GeneProof Hepatitis B Virus (HBV) PCR Kit - Indonesia BPOM Medical Device Registration
GeneProof Hepatitis B Virus (HBV) PCR Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305220009. The device is manufactured by GENEPROOF A.S. from Czech Republic, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. BIOSAINS MEDIKA INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
GENEPROOF A.S.Country of Origin
Czech Republic
Authorized Representative
PT. BIOSAINS MEDIKA INDONESIAAR Address
PERMATA DEPOK MUTIARA BLOK.A NO.7 RT.001/RW.007 KELURAHAN PONDOK JAYA KECAMATAN CIPAYUNG KOTA DEPOK
Registration Date
Jan 14, 2022
Expiry Date
Mar 26, 2026
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
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