ARIA Covid-19 Ag Rapid Test - Indonesia BPOM Medical Device Registration
ARIA Covid-19 Ag Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303120629. 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 HERMAN MEDTEK DIAGNOSTICS.
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
HERMAN MEDTEK DIAGNOSTICSAR Address
Jl. Lingkar Luar Barat, Puri Kembangan, Komplek Rukan Puri Mansion Blok A No.16 Kel.Kembangan Selatan Kec.Kembangan, Kota Jakarta Barat, DKI Jakarta
Registration Date
Dec 15, 2021
Expiry Date
Jan 26, 2026
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
ARIA hCG Combo Rapid Test
BEIJING GENESEE BIOTECH, INC
ARIA H. Pylori Ag Rapid Test
BEIJING GENESEE BIOTECH, INC.
ARIA H. Pylori Ab Combo Rapid Test
BEIJING GENESEE BIOTECH, INC.
Electroline 100 Li Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
MDX Hemaline 300 Diluent
URIT MEDICAL ELECTRONIC CO., LTD.
MDX Hemaline 500 Analyzer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD.
MDX Hemaline 300 Analyzer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD.
ARIA FOB-Hi Rapid Test
BEIJING GENESEE BIOTECH, INC
ARIA PSA Semi-Quantitative Rapid Test
BEIJING GENESEE BIOTECH, INC
ARIA Duo Dengue Ag-IgG/IgM Rapid Test
BEIJING GENESEE BIOTECH, INC