Description
Features:
- For use under an Emergency Use Authorization (EUA) only for the duration of the COVID-19 declaration justifying the emergency use of in vitro diagnostics (IVD), unless it is terminated or revoked by the FDA (after which the test may no longer be used)
- For professional use only.
- For prescription use only.
- The Celltrion DiaTrust COVID-19 Ag Rapid Test is authorized for use in laboratories in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high, moderate or waived complexity tests.
- This test is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- Please refer to the Celltrion DiaTrust COVID-19 Ag Rapid Test instructions for use for additional information.
Contents Per Box Include:
- Test devices packaged individually in aluminum pouch (25 test/box)
- Disposable test tube with 0.3 mL of extraction buffer (25 ea/box)
- Filter cap (25 ea/box)
- Sterilized swabs for specimen collection (25 ea/box)
- Quick reference instruction (1 ea)
- Positive control swab (1 ea/box)
- Negative control swab (1 ea/box)
| Brand | Celltrion |
| Product |
Covid-19 Test Kit |
| Packaging | 25 tests/box, 24 boxes/case |