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PURCHASING AGREEMENT: Cellex Antigen and Antibody Tests

This Public Health Emergency Test Device Purchase Agreement ("Agreement") is entered into by and between HealthDatix, Inc. ("Company") and the purchaser identified below ("Purchaser"), is effective as of date of the Purchaser's Agreement and remains in effect until the Agreement is no longer required or the COVID-19 test device receives full regulatory clearance for the United States market.

The Purchaser agrees that the COVID-19 Rapid Test Devices purchased from the Company ("Tests") fall within the scope of the FDA guidance document issued on May 4, 2020 (https://www.fda.gov/media/135659/download) which allows such tests to be sold into the US market for at Point of Care and under surveillance testing protocol provided they are done so with the following reporting requirements:

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic PCR conformity test should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • Not for the screening of donated blood.
The Purchaser shall comply with the product labeling and report requirements. The tests are limited to use by laboratories or by healthcare workers at point-of-care sites.

By entering your code and pressing Agree, the Purchaser agrees to indemnify, defend and hold harmless Company and its officers, directors, shareholders, employees, agents, representatives, successors and assigns from any and all claims, demands, losses, liabilities, judgments, awards and costs (including attorney’s) fees arising out of or relating to the breach of this Agreement by the Purchaser or any person affiliated with the Purchaser.

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