OnSite Dengue Ag Rapid Test - Indonesia BPOM Medical Device Registration
OnSite Dengue Ag Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303124115. The device is manufactured by CTK BIOTECH, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is 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
RAJAERBA INDOCHEMAR Address
Jl. Hj. Tutty Alawiyah No. 8, Desa/Kelurahan Duren Tiga, Kec. Pancoran, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12760
Registration Date
Oct 28, 2024
Expiry Date
Sep 09, 2027
Product Type
Serological Reagents
Dengue virus serological reagents
Invitro Diagnostics
OnSite Syphilis Ab Combo Rapid Test
OnSite Duo Dengue Ag-IgG/IgM Rapid Test
OnSite Malaria Pf/Pan Ag Rapid Test
OnSiteยฎ Dengue IgG/IgM Combo Rapid Test
OnSite COVID-19 IgG/IgM Rapid Test
RaFIA AMH FIA Test
RaFIA Progesterone FIA Test
OnSite HIV 1/2 Ab Plus Combo Rapid Test
RapidLight Total T3 CLIA Test
ONSITE FOB-Hi Rapid Test
BERIGHT HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma)
HANGZHOU ALLTEST BIOTECH CO., LTD.
COMBIWIDAL 'H' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.
BERIGHT HCV Rapid Test Cassette (Whole Blood/Serum/Plasma)
HANGZHOU ALLTEST BIOTECH CO., LTD.
BERIGHT H. pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma)
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COMBIWIDAL 'BO' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.
COMBIWIDAL 'O' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.
COMBIWIDAL 'AO' Antigen Slide & Tube Test Method
GENUINE BIOSYSTEM PVT LMT.
BERIGHT Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma)
HANGZHOU ALLTEST BIOTECH CO., LTD.
BERIGHT Dengue NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma)
HANGZHOU ALLTEST BIOTECH CO., LTD.
LYSUN Multifunction Analysis Meter (Glucose, Uric Acid)
HANGZHOU LYSUN BIOTECHNOLOGY CO., LTD.

