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.
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:
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 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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Hepatitis B Surface Antigen (Hbsag) Rapi... →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 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.
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
