HIGHTOP HBsAg Rapid Test Kit - Indonesia BPOM Medical Device Registration
HIGHTOP HBsAg Rapid Test Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305220200. The device is manufactured by QINGDAO HIGHTOP BIOTECH CO., LTD from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. PERFECT MEDILAB INDONESIA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
QINGDAO HIGHTOP BIOTECH CO., LTDCountry of Origin
China
Authorized Representative
PT. PERFECT MEDILAB INDONESIAAR Address
jl.Bunga Wijaya Kesuma Psr.IV No.11 Titi Rante
Registration Date
Jul 11, 2022
Expiry Date
Dec 09, 2026
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
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