DrugTestsInBulk.Com is engaged in the business of selling Infectious Disease & Drug/Alcohol Testing Devices.
DrugTestsInBulk.Com wishes to sell and transfer, and you, the Buyer wishes to purchase and acquire, certain goods from DrugTestsInBulk.Com.
The parties therefore agree as follows:
1. AGREEMENT OF PURCHASE AND SALE:
Due to the nature of the tests, once the tests have shipped, there will be no refunds or exchanges for any reason.
2. PAYMENT TERMS:
Payment: Full payment for the product is due at the time of order. Payment may be made by wire transfer, corporate check, ACH or Credit Card (credit card may be used for orders under $10,000.00 USD.)
3. TYPE OF USE:
This product has not been FDA cleared or approved, but has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform high or moderate complexity, or waived tests. This product is authorized for use at the Point of Care (POC), e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
This test is not for "At Home"
Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these
The Buyer shall comply with the Policy guidance including, but not limited to, validation, FDA notification, reporting of results, Emergency Use Authorization (“EUA”), clinical testing and distribution. The Tests shall not be made available, sold, distributed or marketed, directly or indirectly for home use.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S. C. § 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked
You, the Purchaser agrees to indemnify, defend and hold harmless DrugTestsInBulk.Com, it’s parent company, and its officers, directors, 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.