Celltrion diatrust spec sheet
WebThe Celltrion DiaTrustTM COVID-19 Ag Rapid Test is a lateral flow immunoassay test. The Celltrion DiaTrustTM COVID-19 Ag Rapid Test is designed to detect antigen from the … 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.
Celltrion diatrust spec sheet
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WebFeb 17, 2024 · Test in the comfort of your own home, and get the knowledge you need, fast. Use Celltrion SafeKey with the Celltrion DiaTrust™ COVID-19 Ag Home Test. Celltrion SafeKey will guide you... 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 …
WebThis Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Celltrion DiaTrust™ COVID-19 Ag Rapid Test. WebCelltrion DiaTrust TM COVID-19 Ag Rapid Test For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use ... Sheet GHS Code for each ingredient Conc. Sodium Azide (26628 - 22-8) Material Safety Data Sheet Acute Tox.2 (oral), H300 Acute Tox.1 (dermal), H310
WebIntended Use. The Celltrion DiaTrust™ COVID-19 Ag Home Test is a lateral flow immunoas-say intended for the qualitative detection of nucleocapsid protein and receptor-binding domain (RBD) of the SARS-CoV-2 spike proteins in mid-turbinate swabs from the SARS-CoV-2. This test is authorized for non-prescription home use with self-collected … http://www.diatrustcovid.com/assets/pdfs/diatrust-home-notification-shelf-life-extension.pdf
WebSPECIFICATIONS: CPT CODE: 87426 CLICK PUSH FIRMLY X10 (305) 603-7449 [email protected] • • 6445 SW 8th Street Miami, FL 33144. Title: MD Celltrion DiaTrust-Ag-KH Created Date:
WebMar 28, 2024 · Celltrion USA, Inc. Celltrion DiaTrust COVID-19 Ag Rapid Test 04/16/2024: Lateral Flow, Visual Read, Serial Screening, Multiple Targets ... (HCP) and Patient Fact Sheets and either the Manufacture ... edr historicalWebThe 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 DiaTrust. TM. COVID-19 Ag Rapid Test is only for . in vitro. diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. ed rhue rio ranchoWebFACT SHEET FOR HEALTHCARE PROVIDERS Celltrion USA, Inc. October 21, 2024 Celltrion DiaTrustTM COVID-19 Ag Home Test Coronavirus Disease 2024 (COVID -19) This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Celltrion DiaTrust™ COVID-19 Ag Home Test. constellate agencyWebA 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 … constellation1 kitchenerWebCelltrion DiaTrustTM Home Test COVID-19 Ag Celltrion TM Home Test COVID-19 Ag Celltrion DiaTrustTM Home Test COVID-19 Ag Ce ll trio n DiaTrust TM H om e Test … edr historical cleanersWebCelltrion DiaTrust™ COVID-19 Ag Rapid Test is a rapid test based on lateral flow immunoassay intended for the qualitative detection of nucleocapsid and receptor binding … constellation 2 seagateWebRepresenting: 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 constellate literary journal