Syphilis Rapid Test Kits Suppliers & Bulk Manufacturers
Available Forms: Lateral flow immunoassay/Dipstick or strip formats
Available Strengths: high sensitivity and specificity
Reference Brands: Chembio Syphilis Screen & Confirm, SD Bioline Syphilis, Abbott Determine Syphilis(US)
Category: Rapid Test Kits
Syphilis rapid test kits detect Treponema pallidum antibodies (IgG/IgM) using immunochromatography. They provide quick, accurate results within 15-20 minutes, enabling early diagnosis, prompt treatment, and reducing disease transmission. These tests are vital for bedside screening, outbreak control, and improving access in resource-limited settings.
Product Description:
Syphilis 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 approval is required, while in the EU, CE marking ensures compliance with in vitro diagnostic regulations. These kits undergo rigorous validation, clinical performance testing, stability assessments, and quality audits. Proper documentation includes safety profiles, performance data, and certification details. For detailed licensing, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Staying informed on global regulatory standards ensures the deployment of reliable, efficient syphilis testing solutions for early diagnosis and outbreak control worldwide.
Syphilis Rapid Test Kits — third party manufacturing & bulk supply
Syphilis 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 Syphilis 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 Syphilis Rapid Test Kits →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 antibodies to Treponema pallidum, the causative organism of Syphilis, in human blood samples to aid in diagnosis and screening.
It is based on lateral flow immunoassay technology using recombinant Treponema pallidum antigens, nitrocellulose membrane strips, and labeled conjugates such as colloidal gold for antibody detection.
It is marketed under multiple trade names such as Determine Syphilis TP, SD BIOLINE Syphilis 3.0, VISITECT Syphilis Test, OnSite Syphilis Rapid Test, and NADAL Syphilis Test.
It is manufactured by multiple companies including Abbott Diagnostics, SD Biosensor, CTK Biotech, Omega Diagnostics, bioMérieux, Nal von Minden, Meril Diagnostics, J Mitra & Co., Span Diagnostics, and Tulip Diagnostics.
The generic name is Treponema pallidum (TP) Antibody Rapid Diagnostic Test (Lateral Flow Immunoassay).
Common brand names include Determine Syphilis TP, SD BIOLINE Syphilis 3.0, VISITECT Syphilis Test, and OnSite Syphilis Rapid Test.
These kits are manufactured globally in regions including the United States, European Union countries, India, China, and South Korea by various diagnostic companies.
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