Disclaimer

Medical Disclaimer for Non-FDA Approved Blood Test

Introduction

This medical disclaimer (“Disclaimer”) is intended to provide important information regarding the use of the suPAR Biomarker Test (the “Test”), a blood test developed and clinically validated worldwide. The Test is designed to offer insights into your health status but has not been approved by the U.S. Food and Drug Administration (FDA). Please read this Disclaimer carefully before using the Test or relying on its results. By utilizing the Test, you acknowledge and agree to the terms outlined in this Disclaimer.

1. Informational and Educational Purpose Only

The Test and any information provided in connection with it are intended for informational and educational purposes only. The Test is not designed to diagnose, treat, cure, or prevent any disease or condition. The information obtained from the Test should not be used as a definitive diagnostic tool or as a substitute for professional medical advice, diagnosis, or treatment. The Test results are intended to complement, not replace, the care provided by qualified healthcare professionals. FOR INFORMATION PURPOSES ONLY.

2. Consultation with Healthcare Professionals

We strongly encourage you to consult with a licensed healthcare provider or physician to discuss your Test results and determine the appropriate course of action. Your healthcare provider is best equipped to interpret the results in the context of your overall health and medical history. Do not ignore professional medical advice or delay seeking medical care based on the information provided by the Test. Always seek the advice of your healthcare provider for any questions regarding a medical condition or treatment.

3. Non-FDA Approval Disclosure

The suPAR Biomarker Test has been clinically validated and is CE-IVD marked for use in Europe, demonstrating compliance with European Union regulations for in vitro diagnostic medical devices. However, this Test has not been reviewed or approved by the U.S. Food and Drug Administration (FDA). As such, the Test should not be used for clinical decision-making within the United States unless otherwise indicated by your healthcare provider. This Test is provided on an “As Is” basis without any warranties, express or implied, regarding its fitness for any particular medical purpose within jurisdictions requiring FDA approval.

4. Limitation of Liability

The use of the Test and reliance on its results are solely at your own risk. suPAR Health LLC and its affiliates, licensors, and suppliers shall not be held liable for any loss, damage, or harm arising from the use of the Test, reliance on the results, or any decision made based on the information provided. By using the Test, you agree to release suPAR Health LLC from any and all liability associated with its use, including but not limited to incorrect interpretations, improper usage, or adverse outcomes.

5. Research Use Statement (If Applicable)

In certain cases, the Test may be provided for research or investigational purposes only and is not intended for routine clinical use. If the Test is labeled for research purposes, it should not be used to make medical decisions or substitute for established diagnostic methods. Please consult with your healthcare provider or research coordinator for guidance on the appropriate use of the Test in such contexts.

6. No Doctor-Patient Relationship

The use of the Test does not establish a doctor-patient relationship between you and suPAR Health LLC or any of its representatives. The information provided by the Test is not intended to create such a relationship and should not be construed as medical advice, diagnosis, or treatment. All medical concerns should be directed to your healthcare provider.

7. High suPAR Scores

The suPAR Biomarker Test provides results that include a suPAR score, which may indicate certain health conditions or risks. Regardless of the suPAR score level, suPAR Health LLC bears no liability or responsibility for consulting, treating, or notifying individuals based on their score. All users of the Test—whether individuals or physicians—are wholly responsible for interpreting the results and taking appropriate action. Physicians and purchasing entities are entirely responsible for communicating the results to their patients, and individuals are encouraged to consult their healthcare provider. The same protocol for result communication applies irrespective of score level. FOR INFORMATION PURPOSES ONLY.

8. No Liability in Laboratory Sample Processing

suPAR Health LLC assumes no liability for any errors, delays, or issues arising during the laboratory sample collection, transport, or processing phases. By using the Test, you agree that suPAR Health LLC and its affiliated laboratories are not responsible for any damages or adverse outcomes related to laboratory procedures.

Additional Considerations

A. Accuracy and Limitations

While the suPAR Biomarker Test has been clinically validated and is based on robust scientific methodologies, no diagnostic or informational tool is free from limitations. The accuracy and reliability of the Test may be influenced by various factors, including but not limited to sample quality, user compliance with test instructions, and inherent biological variability. suPAR Health LLC does not guarantee that the Test results will be error-free or applicable to every individual’s unique health circumstances.

B. Third-Party Information

The Test may reference third-party information, including clinical studies, peer-reviewed research, or external health resources. While every effort has been made to ensure the accuracy of such information, suPAR Health LLC does not assume responsibility for errors, omissions, or discrepancies in third-party data. Users are encouraged to verify such information independently or consult with healthcare professionals.

C. Informed Consent

By purchasing and using the Test, you acknowledge that you have read and understood the limitations and intended use of the Test. You further consent to the collection, analysis, and reporting of your biological sample as described in the accompanying documentation. Your sample will be handled in compliance with applicable privacy laws and ethical guidelines.

D. International Use

The Test is subject to varying regulatory requirements in different jurisdictions. Users outside the European Union and the United States are responsible for ensuring compliance with local laws and regulations governing in vitro diagnostic devices. suPAR Health LLC makes no representation regarding the availability or legality of the Test in any particular location.

E. Updates to Disclaimer

This Disclaimer may be updated periodically to reflect changes in regulatory requirements, scientific advancements, or business practices. Users are encouraged to review the most current version of the Disclaimer before using the Test.

F. Privacy and Data Security

The privacy and confidentiality of your personal and health information are of utmost importance to us. Please refer to our Privacy Policy for details on how your data will be collected, stored, and used in connection with the Test. By using the Test, you agree to the terms of our Privacy Policy.

G. Governing Law and Jurisdiction

This Disclaimer shall be governed by and construed in accordance with the laws of Puerto Rico. Any disputes arising from the use of the Test shall be subject to the exclusive jurisdiction of the courts located in Puerto Rico.

Conclusion

The suPAR Biomarker Test offers an innovative approach to understanding your health but is not a substitute for professional medical care. By using the Test, you accept its limitations and agree to use it responsibly in consultation with a healthcare provider. For any questions or concerns, please contact suPAR Health LLC at [Contact Information].

This Disclaimer is effective as of [Date].

10. Contact Information

For questions or additional support regarding these policies, Resellers can contact suPAR Health at:

suPAR Health LLC

1511 Ave de la Constitución, Ste 2

San Juan, PR 00909

Puerto Rico

contact@suparhealth.com

By purchasing test kits for resale from suPAR Health LLC, Resellers acknowledge that they have read, understood, and agree to be bound by these Reseller Terms & Policies.