Blood Glucose Rapid Test Strips (glucometers)

Form: Test strips/Portable, single-use strip

Strength: CE-marked for accuracy in 20-600 mg/dL

Reference Brands: Accu-Chek, OneTouch, FreeStyle, Contour, Bayer, GlucoSure

Category: Rapid Test Kits

Blood glucose rapid test strips for glucometers are approved in both the US and EU, supported by dossiers demonstrating high accuracy, safety, and quality assurance in compliance with GMP and IVDR standards. In the US, FDA clearance is required, while in the EU, CE marking certifies adherence to in vitro diagnostic regulations. These test strips undergo rigorous validation, performance testing, and stability assessments. Proper documentation includes safety profiles, clinical data, performance metrics, and manufacturing details. For detailed licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees reliable, rapid blood glucose measurement supporting effective diabetes management worldwide.