Syphilis Rapid Test Kits bulk supplier for pharma manufacturers

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)

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.

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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:

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

Syphilis Rapid Test Kits is supplied as Lateral flow immunoassay/Dipstick or strip formats — 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 Syphilis 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 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.