Hepatitis B Surface Antigen (HBsAg) Rapid Test Kits bulk supplier for pharma manufacturers

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)

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.

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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.

Hepatitis B Surface Antigen (Hbsag) Rapid Test Kits — third party manufacturing & bulk supply

Hepatitis B Surface Antigen (Hbsag) Rapid Test Kits is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Hepatitis B Surface Antigen (Hbsag) Rapid Test Kits is supplied as Lateral Flow Immunoassay (Dipstick) — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Hepatitis B Surface Antigen (Hbsag) Rapid Test Kits listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

It is used as a primary marker for the detection and diagnosis of Hepatitis B infection by identifying the presence of viral surface antigen in blood.

HBsAg itself is a protein antigen present on the surface of the Hepatitis B virus, and diagnostic kits use specific antibodies against this antigen along with immunoassay components such as membranes and labeled conjugates.

It is not sold as a standalone drug but is detected through test kits marketed under trade names such as Determine HBsAg, SD BIOLINE HBsAg, Vikia HBsAg, and HEPACARD.

HBsAg detection kits are manufactured by companies such as Abbott Diagnostics, SD Biosensor, CTK Biotech, bioMérieux, Nal von Minden, J Mitra & Co., Span Diagnostics, Tulip Diagnostics, and Meril Diagnostics.

The generic name is Hepatitis B Surface Antigen (HBsAg).

There is no single brand name for the antigen itself; however, it is detected using branded kits such as Determine HBsAg, SD BIOLINE HBsAg, OnSite HBsAg Rapid Test, and HEPACARD.

The antigen is part of the Hepatitis B virus, while diagnostic kits for its detection are manufactured globally across the United States, Europe, India, China, and South Korea.