CK-MB Rapid Test Kits

Form: Lateral flow immunoassay/Dipstick or strip formats

Strength: Detects CK-MB isoenzyme levels, typically >3-5 ng/mL

Reference Brands: NovaTec CK-MB, Aurora Biomed, Abaxis(US)

Category: Rapid Test Kits

CK-MB rapid test kits are approved in both the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing 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, stability assessments, and quality audits. Proper documentation includes safety data, performance metrics, and certification details. For detailed licensing procedures, approved dossiers, and latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees reliable, rapid cardiac diagnostics to support early myocardial infarction detection worldwide.