Medical device product disclaimer policy

Last Updated: 30th July 2025

Important Notice About Our Products

All rapid diagnostic test kits sold by Newfoundland Diagnostics Ltd are:

• For informational and screening purposes only
• Not intended to diagnose, treat, cure, or prevent any disease
• Not a substitute for professional medical advice, diagnosis, or treatment

FDA Registration Status

Newfoundland Diagnostics Ltd is registered with the U.S. Food and Drug Administration (FDA) as a medical device distributor. Our FDA registration number is 3031231787.

Important: FDA registration as a distributor does not imply FDA approval or endorsement of the products we distribute. All products are manufactured by third parties and carry their own FDA clearances or registrations.

Product Accuracy

Any accuracy claims are provided by the manufacturer based on their clinical studies and FDA submissions. Newfoundland Diagnostics Ltd does not independently verify these claims and relies on manufacturer-provided information.

Test Results and Medical Decisions

• Always consult a healthcare provider to confirm any test results
• Do not make medical decisions based solely on these test results
• The tests results are not a medical diagnosis
• Test results may be affected by various factors including user error, storage conditions, and individual circumstances
• False positives and false negatives can occur with any diagnostic test

Over-the-Counter (OTC) Status

Our products are FDA-cleared for over-the-counter sale, meaning:

• No prescription is required
• Tests are designed for self-administration at home
• Results are for personal information only

Manufacturer Responsibility

All products are manufactured by third parties. The manufacturer bears sole responsibility for:

• Product design and performance
• Clinical accuracy claims
• Product defects or malfunctions
• Compliance with FDA regulations for the device

Adverse Event Reporting

If you experience any adverse events or product malfunctions, please:

1. Contact us immediately at info@newfoundland.io
2. Report directly to the FDA through MedWatch at www.fda.gov/medwatch or 1-800-FDA-1088
3. Retain the product and packaging for investigation if requested

No Medical Advice

Nothing on our website or in our communications constitutes medical advice. We are not healthcare providers and cannot provide medical consultation, interpretation of results, or treatment recommendations.

By purchasing our products, you acknowledge that you have read and understood this disclaimer.