OnSite COVID-19 Ag Rapid Test - Indonesia BPOM Medical Device Registration
OnSite COVID-19 Ag Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303120548. 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.
This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
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
Jul 22, 2021
Expiry Date
Jan 07, 2025
Product Type
Serological Reagents
Respiratory viral panel multiplex nucleic acid assay
Invitro Diagnostics
OnSite Syphilis Ab Combo Rapid Test
OnSite Duo Dengue Ag-IgG/IgM Rapid Test
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
GENUINE BIOSYSTEM PVT LMT.
REIGED DIAGNOSTICS Blood Gas, Electrolyte, Metabolite Control
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
LYSUN Uric Acid Test Strip
HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.
REIGED DIAGNOSTICS Blood Gas Testing Cartridge
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
BIOLAB DIAGNOSTICS Rapid Widal S. Typhi 'O'
BIOLAB DIAGNOSTICS [I] PVT. LTD.
REIGED DIAGNOSTICS Blood Gas Analyzer
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
REIGED DIAGNOSTICS Anti-AB Monoclonal
GENUINE BIOSYSTEM PVT LMT.
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.