WebThe Celltrion DiaTrust. TM COVID-19 Ag Rapid Test is intended for use by professionals or healthcare operators who are proficient in performing ests in point of caret settings. The Celltrion DiaTrustTM COVID-19 Ag Rapid Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. WebFDA also granted Celltrion a shelf-life extension from 1 2 months to 18 months for the Celltrion Diatrust™ COVID-19 Ag Rapid Tests when unopened and stored accordingly to labeled packaging and handling instructions. The affected lot numbers can be found in Appendix I – Table 2Shelf. -Life Extended Lot Numbers.

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WebOct 5, 2024 · Celltrion USA, Inc. Celltrion DiaTrustTM COVID-19 Ag Rapid Test This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Celltrion DiaTrust ... show me change

Celltrion Receives FDA Emergency Use Authorization for Point of …

WebRepresenting: Celltrion USA, Inc. 2520 Meridian Parkway, Suite 200 Durham, NC 27713 Device: Celltrion DiaTrust COVID-19 Ag Rapid Test EUA Number: EUA210190 Company: Celltrion USA, Inc. Indication: Qualitative detection of nucleocapsid and receptor binding domains (RBDs) from the SARS-CoV-2 in human nasopharyngeal WebWhat is the Celltrion DiaTrust™ COVID-19 Ag Home Test? Celltrion DiaTrust™ COVID-19 Ag Home Test is a type of test called an antigen test. Antigen test are designed to … On March 2, 2024, FDA also granted Celltrion a shelf-life extension from 18 … WebA paper copy of the instructions for use can be requested without additional cost. Please contact Celltrion USA, Inc. at < (201) 499-1844> or to obtain … show me center schedule