HIV 1/2 Rapid Test Kits bulk supplier for pharma manufacturers

Hiv 1/2 Rapid Test Kits Suppliers & Bulk Manufacturers

Available Forms: Lateral Flow Cassette Tests

Available Strengths: Detection limits typically 100–200 copies/mL of blood. & Sensitivity & Specificity: >98%

Reference Brands: OraQuick, Determine (Abbott), SD Bioline(EU & US)

HIV 1/2 rapid lateral flow cassette tests detect antibodies to HIV-1 and HIV-2 in blood, saliva, or urine within 15-30 minutes. They support quick diagnosis, facilitate community screening, reduce transmission, and enable immediate counseling and linkage to care, supporting public health efforts worldwide.

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Product Description:

HIV Lateral Flow Cassette Tests require CE marking under IVDR in the EU and FDA 510(k) clearance in the US for legal market entry. EU regulations demand clinical performance evaluation, risk analysis, and QMS under ISO 13485. In the US, analytical and clinical performance data are vital for approval. A well-structured CTD dossier including stability, validation, and IFU ensures compliance and builds buyer trust. Pharmatradz provides regulatory-ready dossiers and sourcing support for HIV rapid test kits to ease your entry into regulated markets.

Hiv 1/2 Rapid Test Kits — third party manufacturing & bulk supply

Hiv 1/2 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

Hiv 1/2 Rapid Test Kits is supplied as Lateral Flow Cassette Tests — 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 Hiv 1/2 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

HIV 1/2 Rapid Test Kits is listed as Lateral Flow Cassette Tests in Detection limits typically 100–200 copies/mL of blood. & Sensitivity & Specificity: >98%. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

HIV 1/2 Rapid Test Kits is referenced against OraQuick, Determine (Abbott), SD Bioline(EU & US). Reference brands are shown for identification only and remain the property of their respective trademark owners.