FDA Disclaimer

General Disclaimer

Product information provided on this website is for general informational purposes only. Regulatory status may vary by product. Certain products offered by Kay Scientific may be FDA cleared, FDA authorized, CLIA waived, intended for over-the-counter use, professional use, or "For Forensic Use Only," as specifically indicated on individual product pages and manufacturer labeling.

The availability of a product on this website should not be interpreted as representing that the product is FDA approved, cleared, authorized, or CLIA waived unless expressly stated.

Structure/Function Claim Disclosure

Note: Any statements regarding the health, function, or performance of specific products have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

Customer Responsibility

Customers are responsible for reviewing and following all applicable product labeling, Instructions for Use (IFU), and intended-use restrictions before purchase or use. It is the customer's responsibility to ensure they maintain all necessary licenses, certifications (such as CLIA certificates), and adhere to all applicable federal, state, and local requirements.

Information provided by Kay Scientific is intended to support, not replace, manufacturer instructions, professional medical advice, laboratory validation, or applicable regulatory guidance.

Questions?

For questions regarding the regulatory status, intended use, or compliance requirements of a specific product, please contact Kay Scientific directly at info@kayscientific.com or (619) 271-2059.