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PPE Orders
Please note: Certain PPE orders may be fulfilled with similar products made by different manufacturers. By purchasing them, you agree to any necessary substitution. There are also no refunds of any of our products because of COVID-19.
Disclaimer Agreement for the COV-19C20CS CareStart COVID-19 Antigen Test
New customers must complete this disclaimer agreement (hereinafter referred to as “Agreement”) form prior to shipment.
1. FDA Regulations and Limitations of Use
In compliance with the US FDA Emergency Use Authorization (EUA) for the CareStart COVID-19 Antigen Test, this Agreement is to ensure your receipt, understanding, and compliance with the terms of this EUA. The full EUA can be found at the link here:
https://www.fda.gov/media/142916/download
Although not limited to the following, we would like to clearly outline some notable points from this Emergency Use Authorization:
Authorized Laboratories
– Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Additional Points
– This test has not been FDA cleared or approved.
– This test has been authorized by FDA under an EUA for use by authorized laboratories.
– This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
– This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of
in vitro diagnostics for 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 authorization is terminated or revoked sooner.
– Authorized laboratories using your product will use your product as outlined in the authorized labeling. Deviations from the
authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.
– Authorized laboratories that receive your product will notify the relevant public health authorities of their intent to run your product prior to initiating testing.
ALL CRITERIA OUTLINED IN THE EMERGENCY USE AUTHORIZATION ARE APPLICABLE TO SALE, RESALE, AND USE OF THE CARESTART COVID-19 ANTIGEN TEST AND ARE NOT RESTRICTED TO ONLY THOSE NOTED ABOVE.
By signing this Agreement you, as a registered signing authority for your company, are acknowledging receipt and compliance to the terms outlined above. In signing, you and the company you are representing agree to indemnify and hold harmless Clinicare Diagnostics LLC and any parties that are used to fulfill your order from any and all fines, damages, losses, costs and expenses incurred as a result of any breach of this Agreement by yourself or any third party introduced to this the product by your company.