DECEMBER 8, 2020 Albany, NY

“Governor Cuomo Congratulates SUNY Upstate Medical on #1 FDA Ranking Among COVID-19 Saliva Tests for Detecting Virus In Earliest Stages”


Clarifi COVID-19 Saliva Test Features

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

spec sheet

Download The Testing Solutions Overview

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Is Clarifi right for your organization?

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. ClarifiCOVID19 has been authorized only for the detection of nucleic acid from SARSCoV2, 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.