Urine hCG Pregnancy Test Kits

Form: Strip/Midstream/Cassette

Strength: Usually detect hCG levels ≥20 mIU/mL

Reference Brands: First Response, Clearblue, EPT (Clearblue), AccuMed, LabAb(US)

Category: Rapid Test Kits

Urine hCG pregnancy test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and quality in compliance with GMP and IVDR standards. In the US, FDA clearance is required, while in the EU, CE marking ensures conformity with in vitro diagnostic regulations. These kits undergo rigorous validation, clinical performance testing, and stability assessments. Documentation includes safety profiles, performance data, and manufacturing details. For detailed licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Staying informed ensures quality, reliable, and compliant pregnancy testing solutions for both clinical and home-use markets worldwide.