*See Table 2C of the FDA reference panel forhttps://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-dataDownload spec sheet
Patient-friendly, non-invasive saliva swab
No cross-reactivity with substances commonly found in saliva such as blood, toothpaste, mouthwash, etc.
Emergency Use Authorization (EUA) issued by the FDA*
Fully multiplexed, efficient for testing laboratories
Contains collection device, extraction kit, and master mix components required to run test
This test kit is not a direct to consumer test, nor a testing service for health care providers. This test kit is sold only to clinical laboratories in quantity. There are no single kit sales of this product at this time.
NOTE: Testing is limited to qualified laboratories in the United States, certified under the Clinical Laboratory Improvement Amendment of 1988 (CLIA), 42 U.S.C. ss 263a, to perform high complexity testing.
*On September 22, 2020, The Clarifi COVID-19 Test Kit obtained Emergency User Authorization(EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.The Clarifi COVID-19 test Letter of Authorization, along with the authorization Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients and authorized labeling are available on the FDA website.
The Clarifi COVID-19 Test Kit has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. ClarifiCOVID19 has been authorized only for the detection of nucleic acid from SARSCoV2, not for any other viruses or pathogens, and 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.