ONE STEP Cassette Style Anti HIV 1+2 Rapid Screen Test (Whole Blood) - Indonesia BPOM Medical Device Registration
ONE STEP Cassette Style Anti HIV 1+2 Rapid Screen Test (Whole Blood) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305220581. The device is manufactured by NANTONG EGENS BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. DANPAC PHARMA.
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Risk Classification
Product Class
Kelas : 3
Manufacturer
NANTONG EGENS BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. DANPAC PHARMAAR Address
Plaza Asia, Lt. 6D, Kav. 59, RT 005/RW 003
Registration Date
Dec 06, 2022
Expiry Date
Nov 30, 2027
Product Type
Immunological Test System
Multiple autoantibodies immunological test system.
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