FDA compliance statement

Newfoundland Diagnostics Ltd is registered with the U.S. Food and Drug Administration as a distributor of medical devices.

• • FDA Registration Number: 3031231787
  • Registration Type: Foreign Private Label Distributor
  • Product Category: Over-the-Counter (OTC) In Vitro Diagnostic Devices
  • Registered Address: 3a Station Road, Amersham, Buckinghamshire, HP7 0BQ, United Kingdom

As an FDA-registered distributor of OTC devices:

• We maintain proper storage and handling procedures
  • We ensure product traceability
  • We report adverse events to manufacturers and FDA as required
  • We distribute only FDA-cleared or approved devices
  • We comply with FDA regulations for OTC device distribution

• We are not the manufacturer of these devices
  • FDA registration is not FDA approval of our company
  • We do not modify or repackage the devices
  • We cannot make claims beyond those approved for the device

Our products are classified as OTC in vitro diagnostic devices, meaning:

• They can be purchased without a prescription
  • They are intended for home use by consumers
  • They have been authorized by FDA for self-testing
  • They do not require CLIA certification for use

We maintain complaint files as required by FDA. If you experience:

• Any malfunction that could cause serious injury
  • Any adverse reaction to a test
  • Any quality issue with a product

Please report it immediately to:

• Us at info@newfoundland.io
  • FDA MedWatch at www.fda.gov/medwatch or 1-800-FDA-1088