HBsAg Rapid Test Kits-Cassette-Based bulk supplier for pharma manufacturers

Hbsag Rapid Test Kits-Cassette-Based Suppliers & Bulk Manufacturers

Available Forms: Cassette-Based Rapid Test Kits

Available Strengths: sensitivity >95%, specificity >99%

Reference Brands: BinaxNOW, OraQuick, STANDARD Q, DPP® HIV/Syphilis Assay(US)

Hepatitis B Surface Antigen (HBsAg) cassette-based rapid test kits detect hepatitis B infection by identifying viral surface antigen in blood or serum using immunochromatography. They provide quick, accurate results within minutes, enabling early diagnosis, timely treatment, and effective infection control, reducing transmission risks.

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Product Description:

Hepatitis B Surface Antigen (HBsAg) cassette-based rapid test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing quality. In the US, FDA clearance is required, while in the EU, CE marking ensures compliance with in vitro diagnostic regulations. These kits undergo rigorous validation, stability testing, and clinical evaluations to meet stringent regulatory standards. Proper documentation includes safety profiles, clinical performance data, and manufacturing practices. For detailed licensing requirements, approved dossiers, and latest regulatory updates, visit Pharmatradz. Stay informed on the global approval landscape to ensure compliance and reliable hepatitis B screening solutions.

Hbsag Rapid Test Kits-Cassette-Based — third party manufacturing & bulk supply

Hbsag Rapid Test Kits-Cassette-Based 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

Hbsag Rapid Test Kits-Cassette-Based is supplied as Cassette-Based Rapid Test Kits — 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 Hbsag Rapid Test Kits-Cassette-Based 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 for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human blood samples to aid in the diagnosis and screening of Hepatitis B infection.

It is based on a lateral flow immunoassay technology using specific antibodies against HBsAg, nitrocellulose membrane strips, and labeled conjugates such as colloidal gold to detect the presence of the antigen in the sample.

It is marketed under multiple trade names globally such as Determine HBsAg, SD BIOLINE HBsAg, OnSite HBsAg Rapid Test, HEPACARD, and Vikia HBsAg.

It is manufactured by multiple companies worldwide including 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) Rapid Diagnostic Test (Lateral Flow Immunoassay).

Common brand names include Determine HBsAg, SD BIOLINE HBsAg, OnSite HBsAg Rapid Test, HEPACARD, and NADAL HBsAg Test.

These kits are manufactured globally across regions including the United States, European Union countries, India, China, and South Korea by various diagnostic companies.