FDA Disclaimer

FDA & Regulatory 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 Forensic Use Only, as specifically indicated on the individual product page and manufacturer labeling.

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

Customers are responsible for reviewing and following all applicable product labeling, Instructions for Use (IFU), intended-use restrictions, warnings, and federal, state, and local requirements before use.

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

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