RaFIA AMH FIA Test - Indonesia BPOM Medical Device Registration
RaFIA AMH FIA Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101323284. 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 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
Jun 17, 2023
Expiry Date
Aug 25, 2026
Product Type
Clinical Chemistry Test System
Anti-Mullerian Hormone Test System (cair)
Invitro Diagnostics
OnSite Syphilis Ab Combo Rapid Test
OnSite Duo Dengue Ag-IgG/IgM Rapid Test
OnSite Malaria Pf/Pan Ag Rapid Test
OnSite® Dengue IgG/IgM Combo Rapid Test
OnSite COVID-19 IgG/IgM Rapid Test
OnSite Dengue Ag Rapid 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)
HANGZHOU ALLTEST BIOTECH CO., LTD.
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.