- Extraction-free molecular COVID-19 detection kit
- 100 tests per kit. MOQ 100 kits
- Results in under 90 minutes
- FDA EUA letter – Link
- Fact Sheet for Patients- Link
- Fact Sheet for Providers – Link
- Instruction For Use – Link
- Made in the USA
- 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 nucleic acid from SARSCoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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