Celltrion DiaTrustTM COVID-19 Ag Rapid Test (25 Tests Per Box)
- Only for use under an Emergency Use Authorization (EUA) during the period of the COVID-19 declaration supporting the use of in vitro diagnostics (IVD) in an emergency, until the FDA terminates or revokes it (after which the test may no longer be used)
- Only for professional use.
- Only for prescription use.
- The Celltrion DiaTrustTM COVID-19 Ag Rapid Test is approved for use in laboratories in the United States and is certified to perform high, moderate, or waived complexity tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a.
- This test is also approved for use in patient care settings that have a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- For further information, see the Celltrion DiaTrustTM COVID-19 Ag Rapid Test directions for use in the IFU Tab below.
Call 440-463-4480 For Availability