Fluorescent validation for diagnostic devices: Confidence built on calibration

Reliable performance is essential for any fluorescence-based diagnostic device, especially when accuracy affects patient outcomes and regulatory approval. However, many instruments lack integrated fluorescence references, leaving calibration vulnerable to drift and device-to-device inconsistency.

Starna Scientific provides a proven solution: custom solid-state fluorescent references engineered for your device geometry and assay. Designed to match your optical configuration and concentration requirements, each reference integrates seamlessly into your platform, delivering consistent, verifiable results from development through production without the compromises of off-the-shelf alternatives.

Every reference is manufactured to deliver validated multi-year stability and batch-to-batch consistency under our ISO 17034 (Reference Material Producer) accredited Quality Management System. Production items are tested against on-site master materials; where specified, we validate to primary reference materials from national institutes. Depending on your application, Starna achieves tight coefficients of variance for clinical environments or balance precision with cost-effectiveness for wider deployment.

Starna Scientific’s solid-state fluorescent references are trusted in leading diagnostic platforms worldwide, including immunoassay analysers, microplate readers, and point-of-care systems. Comprehensive traceability documentation supports compliance with FDA 21 CFR 820.72, ASTM E2719, IVDR, and ISO 13485, providing the calibration records and performance verification essential for streamlined validation and successful regulatory submissions.

The company's technical team works in partnership with your engineers and quality specialists from specification through deployment. Whether integrated directly into your device or deployed across R&D and validation, Starna Scientific’s references deliver right-first-time performance you can depend on.

When precision and reliability matter, calibration isn't an afterthought.

Contact Starna Scientific to specify a fluorescent reference that strengthens your device validation and accelerates regulatory approval.

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