ENT diagnostic kits

Form: Rapid test strips, Laboratory-based assays, Point-of-care kits

Strength: Rapid, high sensitivity and specificity, easy-to-use for throat, nasal, and ear infections

Reference Brands: Quidel (Lyme disease, strep), BD Veritor, Alere, CareStart, ImmunoXpert

Category: Medical Devices

ENT diagnostic kits in the EU and US are regulated to ensure safety, efficacy, and quality. In the US, approval from the FDA requires validation, safety testing, and GMP compliance, while in the EU, CE marking certifies conformity with MDR standards. These kits undergo validation, stability testing, and audits, supported by comprehensive documentation including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to reliable, high-quality diagnostic tools critical for timely and accurate detection of ENT infections, supporting effective patient management in healthcare and veterinary practices worldwide.