On June 4, 2021 the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of CovAb SARS-CoV-2 Ab Test pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).
| Device: | CovAb SARS-CoV-2 Ab Test |
| EUA Number: | EUA210017 |
| Company: | Diabetomics, Inc. |
| Indication: | Qualitative detection of total antibodies (including IgG, IgA and IgM) to SARS-CoV-2 in human oral fluid (gingival crevicular fluid – GCF). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Samples should only be tested from individuals that are 15 days or more post symptom onset. Emergency use of this test is limited to authorized laboratories. |
| 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. |
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