Hepatitis B Surface Antigen (Hbsag) Rapid Test Kits Suppliers & Bulk Manufacturers
Available Forms: Lateral Flow Immunoassay (Dipstick)
Available Strengths: sensitivity >95%, specificity >99%
Reference Brands: Alere BinaxNOW, STANDARD® Q, OraQuick, DPP® HIV/Syphilis Assay(US)
Category:
Rapid Test Kits
Hepatitis B Surface Antigen (HBsAg) rapid test kits detect the presence of hepatitis B virus surface antigen using lateral flow immunoassay technology. They provide quick, accurate screening for hepatitis B infection, enabling timely diagnosis, early treatment, and infection control, thereby reducing transmission and preventing complications.
Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits is available in Lateral Flow Immunoassay (Dipstick)
and strengths such as sensitivity >95%, specificity >99%.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
Hepatitis B Surface Antigen (HBsAg) rapid lateral flow immunoassay (dipstick) test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and quality in compliance with GMP and CE marking standards. In the US, FDA approval is required, while in the EU, CE marking ensures compliance with in vitro diagnostic regulations. These kits undergo rigorous clinical validation, stability testing, and manufacturing audits prior to approval. For detailed regulatory insights, licensing procedures, and approved dossiers, visit Pharmatradz. Staying informed on the latest regulatory updates ensures market compliance and reliable hepatitis B screening worldwide.
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