Troponin I Rapid Test Kit

Form: Lateral flow immunoassay/Dipstick or strip formats

Strength: Detects troponin I levels >0.1 ng/mL

Reference Brands: Alere (Abbott) Troponin I, Quidel Triage Troponin I, Osang Troponin I(US)

Category: Rapid Test Kits

Troponin I rapid test kits are approved in the US and EU, supported by dossiers demonstrating high sensitivity, specificity, and manufacturing quality in accordance with GMP and IVDR standards. In the US, FDA clearance is required, while CE marking certifies compliance in the EU. These kits undergo rigorous validation, clinical performance testing, stability assessments, and quality audits before approval. Proper documentation includes safety profiles, performance data, and certification details. For comprehensive licensing information, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Staying informed ensures access to reliable, compliant rapid cardiac diagnostics for timely myocardial infarction detection worldwide.