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Test that are authorized for home use with self-collecting that does not require CLA.
Custom Solution that is adaptive and easily deployable to mitigate legal risk and get people together again
POINT OF CARE TEST:

INDICAID Covid-19 Rapid Test
The INDICAIDTM COVID-19 Rapid Antigen Test is a point-of-care kit designed for the detection of SARS-CoV-2 antigens in direct nasal swab samples. The test is intended for use by healthcare professionals in symptomatic individuals within 5 days after onset of symptoms.
Downloads
FDA EUA Letter
Quick Reference Guide
Fact Sheet for
Health Providers
Fact Sheet for
Patients

Sienna-Clarity COVID-19 Antigen Rapid Test Cassette
The Sienna COVID-19 Antigen Rapid Test Cassette is a rapid
chromatographic immunoassay for the qualitative detection of
COVID-19 antigen in Nasopharyngeal swab. The identification
is based on the monoclonal antibodies specific for the
Nucleocapsid protein of SARS-CoV-2. It is intended for
professional in-vitro diagnostic use only.
Downloads
FDA EUA Letter
User Instructions
Product Information
Sheet

Celltrion DiaTrust COVID-19 Ag Rapid Test
Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare
provider within the first six days of symptom onset. Emergency use of this test is limited to authorized laboratories.
Downloads
FDA EUA Letter
User Instructions
Product Information
Sheet
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