(Box) Status™ COVID-19/Flu A & B Combo Rapid Test Kit CLIA Waived, 25/Bx

A Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from anterior nasal and nasopharyngeal swab specimens

Features and Benefits :

• COVID-19
  • Anterior nasal swab specimen − Sensitivity 93.8 %, Specificity 100%
  • Nasopharyngeal − Sensitivity 93.1 %, Specificity 100%
• Flu A – Sensitivity 91.4%, Specificity 95.7%
• Flu B – Sensitivity 87.6%, Specificity 95.9%
• FDA Emergency Use Authorization (EUA)
• Visually read in 15 minutes
• Flocked nasopharyngeal swab for superior specimen collection and patient comfort
  

Packaging details:

Minimum order quantity: One Box
Packaging Details: 25 Kit/ Box, 20 Boxes/ Case
Weight: 1.1 lbs
Dimensions: 10'' x 6'' x 4''

Instructions for Use:

SellSheet_80645_Lifesign_Status Flu Covid.11.3.21

SDS_COVID_FLU_1

P-52730-E Status Flu 2019 2020 2021 Annual Reactivity Testing Results appendix_0

Covid_Flu_CLSI

03 - EUA210015.S007.Princeton.Biomed.HCP Fact Sheet.05-12-2023

04 - EUA210015.S007.Princeton.Biomed.PATIENT Fact Sheet.05-12-2023

05 - EUA210015.S007.P-5383-E Status COVID-19 Flu QRI procedure card.05-12-2023

06 - EUA210015.S007.Status COVID-19 Flu package insert IFU.05-12-2023