Azure Biotech Inc.
Azure - COVID-19 IgG/IgM Rapid Test Device
This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. It is a point of care test for fingerstick whole blood specimens only. The user should be trained in the procedure. Wear appropriate protective attire for your safety when handling patient samples.
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- This test has been authorized only for the presence of IgM and IgG antibodies against 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.
- Read the complete Quick Reference Instructions before performing the test. For technical assistances, please call (800) 618-5829.
- There should be a blue line in the control region (next to “C”) before testing, discard the device if there is no blue line.
- Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assa