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lifeSign Status™ COVID-19/Flu A&B
Sensitivity: 93.9% Specificity: 100.0%
Sensitivity: 91.4% Specificity: 95.7%
Sensitivity: 87.6% Specificity: 95.9%
Results in 15 Minutes
Status™ COVID-19/Flu is made in the USA.
FDA EUA Authorized. (EUA210015)
Visually read in 15 minutes
Flocked nasopharyngeal swab for superior specimen collection and patient comfort.
Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, 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. Emergency use of this test is limited to authorized laboratories.
Status™ COVID-19/FLU A&B test has been granted emergency use authorization (EUA) by the FDA for use at the point-of-care setting. During the duration of the emergency this test can be performed in a patient care setting that is operating under a CUA Waiver, Certificate of Compliance or Certificate of Accreditation.
Store the Status™ COVID-19/FLU A&B at 1-30˚C (33.8-86 degrees F)
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorization for use at point of care settings.(CLIA-Waived)
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19-FLU A&B under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
CPT COVID-19: 87811QW
FLU A: 87804QW
FLU B: 87804QW-59
Product Name: Status™ COVID-19/Flu A&B
Country of Manufacturer: USA
Sample Type: Nasopharyngeal
COVID-19 – Sensitivity: 93.9% Specificity: 100.0%
Flu A – Sensitivity: 91.4% Specificity: 95.7%
Flu B – Sensitivity: 87.6% Specificity: 95.9%
Test Procedure: 5 steps
Test Run Time (minutes): 15 minutes
Mobile App: No
Package dimensions (25 tests): 11 x 7 x 3 inch
Package Weight (25 tests): 1.05 lbs.
Box Dimensions (375 tests): 21 x 17x 17 inch
Box Weight (375 tests): 15.75 lbs.
Pallet Dimensions (18 boxes): 48x40x60 inches
Pallet Weight (18 boxes): 283.5 lbs.
Swab Included: Yes (Nasopharyngeal)
Storage Temp (In Celsius): 2C-30C
Shelf Life: 6 months from date of manufacturer
Internal Control Included: Yes
EUA Status: FDA EUA Authorized
CE Status: Certified