Cholesterol Testing Devices

Form: Point-of-care blood cholesterol meters, Test strips , Laboratory analyzers

Strength: Measure total cholesterol, HDL, LDL, and triglycerides with rapid results

Reference Brands: Accu-Chek (by Roche), CardioChek (By PTS Diagnostics), Cholestec

Category: Medical Devices

Cholesterol testing devices in the US and EU are regulated to ensure safety, accuracy, and quality. In the US, FDA approval involves clinical validation and safety assessments, while in the EU, CE marking certifies conformity with in vitro diagnostic regulations. Devices undergo validation, stability testing, and quality audits, with 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, accurate cholesterol monitoring solutions essential for cardiovascular health management and disease prevention worldwide.