Strep A Rapid Test Kits bulk supplier for pharma manufacturers

Strep A Rapid Test Kits Suppliers & Bulk Manufacturers

Available Forms: Lateral flow immunoassay/Dipstick or strip formats

Available Strengths: high sensitivity (>90%),

Reference Brands: Quidel QuickVue Strep A, BD Veritor, Sofia Strep A, CareStart Strep(US)

Category: Rapid Test Kits

Strep A Rapid Test Kits is available in Lateral flow immunoassay/Dipstick or strip formats and strengths such as high sensitivity (>90%),. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Strep A Rapid Test Kits is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Strep A Rapid Test Kits can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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Product Description: Strep A rapid test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing quality in compliance with GMP and IVDR standards. In the US, FDA clearance ensures safety and performance, while in the EU, CE marking certifies conformity with in vitro diagnostic regulations. These kits undergo extensive validation, clinical performance testing, stability assessments, and quality audits. Proper documentation includes safety profiles, performance data, and certification details. For detailed licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees reliable, rapid diagnosis of strep throat critical for effective treatment and infection control worldwide.

Frequently Asked Questions

Yes, Strep A Rapid Test Kits is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Strep A Rapid Test Kits is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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