QUALITY ACCESS Syphilis (Treponema Pallidum Antibody) Test Cassette (Whole Blood/Serum/Plasma) - Indonesia BPOM Medical Device Registration
QUALITY ACCESS Syphilis (Treponema Pallidum Antibody) Test Cassette (Whole Blood/Serum/Plasma) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303910325. The device is manufactured by NANTONG EGENS BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. BUANA MITRA SUKSES.
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
NANTONG EGENS BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. BUANA MITRA SUKSESAR Address
RUKO NIAGA KALIMAS I BLOK B 10-11 JL INSPEKSI KALIMALANG
Registration Date
Oct 11, 2021
Expiry Date
Oct 11, 2024
Product Type
Serological Reagents
Treponema pallidum treponemal test reagents.
Invitro Diagnostics
QUALITY ACCESS Syphilis (Treponema Pallidum Antibody) Test Strip (Whole Blood/Serum/Plasma)
QUALITY ACCESS Syphilis (Treponema Pallidum Antibody) Test Cassette (Whole Blood/Serum/Plasma)
Quality Access® HCG Test Cassette (Urine)
Quality Access® HCG Test Strip (Urine)
QUALITY ACCESS HBsAg Test Cassette (WB/Serum/Plasma)
StandaReagen Combo Diagnostic Kit Multi Drug Panel 7 in 1 (AMP/MOP/THC/MET/COC/BZO/SOMA)
EGENS HCG Pregnancy Test
EGENS HCG Pregnancy Test
EGENS One Step Test Device Diagnostic Kit for Amphetamine (Cassette)
EGENS One Step Test Device Dengue NS1 Antigen Serum/Plasma Test, Cassette
ATLAS Rheumatoid Factor (RF) Latex Kit
ATLAS MEDICAL
ATLAS Salmonella OB Reagent
ATLAS MEDICAL.
ATLAS Salmonella OD Reagent
ATLAS MEDICAL.
ATLAS Anti-A Monoclonal Reagent
ATLAS MEDICAL
ATLAS Anti-D IgG/IgM Blend Reagent
ATLAS MEDICAL
ATLAS Salmonella HA Reagent
ATLAS MEDICAL.
BM Diagnostics BM-3D Lyse for BM-H3900S Hematology Analyzer
DIRUI INDUSTRIAL CO., LTD., P.R.
QUALITY ACCESS Tuberculosis Test Cassette (Whole Blood/Serum/Plasma)
ATLAS MEDICAL
ATLAS ASO Latex Kit
ATLAS MEDICAL.
BM Diagnostics BM Probe Cleanser for BM-H3900S Hematology Analyzer
DIRUI INDUSTRIAL CO., LTD., P.R.