
Influenza A/B Rapid Test Kits
Form: Lateral flow immunoassay/Dipstick or strip formats
Strength: high accuracy suitable for point-of-care diagnosis
Reference Brands: Quidel QuickVue Influenza, BD Veritor, Sofia Influenza A+B, Abbott BinaxNOW(US)
Category: Rapid Test Kits
Influenza A/B rapid test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing quality in accordance with GMP and IVDR standards. In the US, FDA clearance ensures performance and safety; in the EU, CE marking certifies compliance 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 comprehensive licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees reliable, rapid influenza detection, enabling timely treatment and infection control across global healthcare settings.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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