ARIA Syphilis Ab Rapid Test - Indonesia BPOM Medical Device Registration
ARIA Syphilis Ab Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303128078. 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 PT. 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
PT. 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
Oct 28, 2021
Expiry Date
Jun 04, 2025
Product Type
Serological Reagents
Treponema pallidum treponemal test reagents.
Invitro Diagnostics
OnSite Syphilis Ab Combo Rapid Test
OnSite Duo Dengue Ag-IgG/IgM Rapid Test
OnSiteยฎ 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
MDX Electroline 100 QC Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 Ca Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 K Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 QC Solution (Ca)
CARETIUM MEDICAL INSTRUMENT CO., LTD.
ELECTROLINE 100 Urine Diluent Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
ELECTROLINE 100 Reference Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 at Conditioner
CARETIUM MEDICAL INSTRUMENT CO., LTD.
Electroline 100 pH Na Cl Electrode Filling Solution
CARETIUM MEDICAL INSTRUMENT CO.LTD.
ARIA Malaria Pf/Pan Ag Rapid Test
BEIJING GENESEE BIOTECH, INC
MDX Hemaline 500 Staining Solution
URIT MEDICAL ELECTRONIC CO., LTD.

