Terms & Conditions

“The standard TruMedical refund policy does not apply for COVID-19 rapid tests. All sales are final once goods are shipped and in transit with courier. No exchanges or refunds will be made.”

Terms for order forms & Invoices – Direct payment

Billing and Payment Terms: Customer will be charged in full upon signing of order form. Payments are due upon receipt of order form unless otherwise agreed upon between both parties. Signature on this order form constitutes agreement with the product and materials order above.100% will be billed and must be paid in full prior to product being shipped or hand delivered. Final shipment info with tracking number will be provided upon full payment of your order. Direct wire transfer, certified check, credit card and ACH payment options available based on billing amount. Shipping & Handling fees apply for all orders placed. Customer can provide shipping account numbers on order form but handling fees still apply on all orders.

Product: This test has received an Emergency Use Authorization from the Federal Drug Administration (FDA). The MobileDetect Bio BCC19 Test Kit is a reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) test intended for the qualitative detection of RNA from the SARSCoV-2 in nasopharyngeal (NP), oropharyngeal (OP), mid-turbinate (MT) and anterior nares (nasal) swab specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories – certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high or moderate complexity tests.

Auto-ship Program: Subject to the commercial availability of Molecular testing, Purchaser will commit to Diagnostic COVID Molecular testing solely from TruMedical Diagnostics and its affiliates for a period of at least 6 months. Seller agrees to offer the Purchaser a 2% discount on tests when purchased each month from the execution of the Order Form. Discount will begin on the 2nd month of re-ordering. By signing below, I acknowledge that I/we fully understand and will abide by the above. I/we further agree to pay the total due indicated above via credit card or wire transfer for the above agreed upon products. I/we understand products will not be shipped until total due is paid-in-full.

UNITED STATES CUSTOMERS: EMERGENCY USE TEST PURCHASE ACKNOWLEDGEMENT

This Emergency Use Test Purchase Acknowledgement (“Agreement”) is entered into by and between the Company (also “Supplier”) and the Client (“Purchaser”) and is effective as of date set forth next to the Buyer’s signature. The Purchaser agrees that the tests purchased by Purchaser from the Company (“Tests”) are for emergency use authorized (EUA) test purposes only and have been approved and licensed for sale or use in the U.S. by the U.S.Food and Drug Administration (“FDA”) under specific EUA guidance. The Tests are provided by Company to Purchaser pursuant to the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency as revised on the web on May 11, 2020 (or as per most recent) by U.S. Food and Drug Administration (“The Policy”), which may be found here: https://www.fda.gov/media/135659/downloadas well as specific information, instructions and evaluation data pertinent to “Tests” use as provided in the “authorized serology test performance” section of the FDA website, (“Serology Section”), available here: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-testperformance

All uses of the tests by the Purchaser shall be consistent with the Policy and Serology Section. Purchaser shall comply with the Policy guidance including, but not limited to, validation, FDA notification, reporting of results, Emergency Use Authorization (“EUA”), clinical testing, claims, restrictions and indications for use and distribution. Collection and interpretation of the Tests shall only be performed by accredited medical professionals. The Tests shall not be made available, sold, distributed or marketed, directly or indirectly, to the general public or outside of their indication for use.

The Purchaser shall not alter, modify, remove or deface the labeling on the Tests.

CE COUNTRIES: SELF DECLARE CE MARK AND TUV AUDIT/LISTING

The Purchaser agrees that the tests purchased by Purchaser from the Company (“Tests”) meet the quality certification level of “CE Mark”, which is a self-declared process, and a certificate has been granted to the Manufacturer. Seller will provide CE certificate, and any other necessary paperwork,

FURTHER ACKNOWLEDGEMENT – ALL POTENTIAL PURCHASERS IN ALL REGIONS

THE TESTS SHALL ONLY BE USED FOR DIAGNOSIS WHEN PERFORMED BY AN APPROPRIATE CLIA CERTIFIED LABORATORY OR UNDER PRELIMINARY SCREENING PURPOSES AS DEFINED BY FDA AND SHALL ONLY BE USED TO DETERMINE IF ADDITIONAL TESTING IS REQUIRED, AND AS DICTATED BY END MARKET REGULATIONS.

The Purchaser shall not alter, modify, remove or deface the labeling on the Tests.

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.