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 detect Group A Streptococcus bacteria in throat swabs using immunoassay technology. They provide quick results within 5-10 minutes, enabling prompt diagnosis and treatment, reducing transmission, and supporting effective outpatient management of strep throat, especially in pediatric and primary care settings.
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.
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.
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