Celltrion DiaTrustTM COVID-19 Ag Rapid Test (25 Tests Per Box)

 Celltrion DiaTrustTM COVID-19 Ag Rapid Test (25 Tests Per Box)

A lateral flow immunoassay test, the Celltrion DiaTrustTM COVID-19 Ag Rapid Test is a Celltrion DiaTrustTM COVID-19 Ag Rapid Test. The Celltrion DiaTrustTM COVID-19 Ag Rapid Test detects antigen from the SARS-CoV-2 in human nasopharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. The Celltrion DiaTrustTM COVID-19 Ag Rapid Test has been validated for use without transport media on direct specimens.

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SKU: RCHM-02071 Category: Tags: , ,
 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

 

IFU

Document: Language: Size:
BPC_InstructionForUse_Pdf English (United States) 6810

 

Quick Reference Instruction

Document: Language: Size:
BPC_QRI_Pdf English (United States) 9810