Description
Status MSDS
Status Package Insert
Status Patient_Fact_Sheet
Status Procedure_Card
Status Provider Fact Sheet
FDA EUA Letter
Regulatory Status: FDA EUA Authorized for use in a POC setting
Contents: Status COVID-19/Flu test devices, individually wrapped (25), Extraction Reagent in capsules (25), Sterile Swabs (25), Positive Control Swab (1), Negative Control Swab (1), Package Insert /Instructions for use (1), Quick Reference Instruction (1)
Determinations: nucleocapsid Antigen from SARS-CoV2, Influenza A and Influenza B
Storage Requirements: 35° – 86° F
Processing Time: 15 Minutes
Status™ COVID-19/Flu test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms.
The Status™ COVID-19/Flu test is intended for use by medical professionals and laboratory personnel trained to perform the test. The Status™ COVID-19/Flu test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
See product links above for additional information or contact your local Stat Technologies sales representative
