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)
Category: Rapid Test Kits
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.
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:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required 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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Hbsag Rapid Test Kits-Cassette-Based →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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.
Related Products
Strep A Rapid Test Kits
Strength:
high sensitivity (>90%),
Form: Lateral flow immunoassay/Dipstick or strip formats
Reference Brands: Quidel QuickVue Strep A, BD Veritor, Sofia Strep A, CareStart Strep(US)
View Details
Influenza A/B Rapid Test Kits
Strength:
high accuracy suitable for point-of-care diagnosis
Form: Lateral flow immunoassay/Dipstick or strip formats
Reference Brands: Quidel QuickVue Influenza, BD Veritor, Sofia Influenza A+B, Abbott BinaxNOW(US)
View Details
Rotavirus Rapid Test Kits
Strength:
High sensitivity (>90%) and specificity
Form: Lateral flow immunoassay/Dipstick or strip formats
Reference Brands: SD Bioline Rotavirus, Quidel QuickVue Rotavirus, Bio-Rad, Premier(US)
View Details
H. Pylori Antigen Rapid Test Kit
Strength:
high sensitivity (>90%)
Form: Cassette-based immunochromatographic test kits/Dipstick or strip formats
Reference Brands: Premier Platinum H. pylori, Schutz, Nova Test, Abnova H. pylori(US)
View DetailsQuick Response Guaranteed | Verified Suppliers
