RaFIA MAU FIA Test - Indonesia BPOM Medical Device Registration
RaFIA MAU FIA Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305220363. The device is manufactured by CTK BIOTECH, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. RAJAERBA INDOCHEM.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
CTK BIOTECH, INC.Country of Origin
United States
Authorized Representative
PT. RAJAERBA INDOCHEMAR Address
GEDUNG PEMBINA GRAHA JL. DI. PANJAITAN NO.45 RAWA BUNGA
Registration Date
Aug 29, 2022
Expiry Date
Aug 25, 2026
Product Type
Immunological Test System
Albumin immunological test system.
Invitro Diagnostics
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OnSite® Dengue IgG/IgM Combo Rapid Test
OnSite Malaria Pf/Pan Ag Rapid Test
OnSite COVID-19 IgG/IgM Rapid Test
OnSite Dengue Ag Rapid Test
RaFIA AMH FIA Test
RaFIA Progesterone FIA Test
OnSite HIV 1/2 Ab Plus Combo Rapid Test
RapidLight Total T3 CLIA Test
REIGED DIAGNOSTICS Anti-D Monoclonal
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REIGED DIAGNOSTICS Blood Gas, Electrolyte, Metabolite Control
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LYSUN Uric Acid Test Strip
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BIOLAB DIAGNOSTICS Rapid Widal S. Typhi 'O'
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REIGED DIAGNOSTICS Blood Gas Analyzer
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REIGED DIAGNOSTICS Anti-AB Monoclonal
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REIGED DIAGNOSTICS Anti-B Monoclonal
GENUINE BIOSYSTEM PVT LMT.
COMBIWIDAL 'CH' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.
REIGED DIAGNOSTICS Anti-A Monoclonal
GENUINE BIOSYSTEM PVT LMT.