Strep A Rapid Test Kits

Form: Lateral flow immunoassay/Dipstick or strip formats

Strength: 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 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.