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 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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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