Rapid Test Kit Status™ Antigen Detection COVID-19 / Flu A and B Nasopharyngeal Swab Sample 25 Tests by LifeSign ID 33225

196-1-3225
      
Stock Est. Shipping Date: 25th April 2025 ⓘ

Rapid Test Kit Status™ Antigen Detection COVID-19 / Flu A and B Nasopharyngeal Swab Sample 25 Tests
Sold by: KT OF 25

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Rally #196-1-3225
LifeSign #33225
Status™ COVID-19/Flu A&B Test (25/KT)

Rapid Test, COVID-19/Flu A&B, Anterior Nasal & NP Swab, Lateral Flow Immunoassay, Rx Only

Features
  • 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
Status™ COVID-19/Flu A&B test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid protein antigen from SARS-CoV-2, influenza A and/or influenza B directly from nasopharyngeal or anterior nasal swab specimens collected from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider- within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The Status™ COVID-19/Flu A&B does not differentiate between SARS-CoV or SARS-CoV-2 viruses.

Results are for the simultaneous in vitro detection and differentiation of nucleocapsid protein antigens of SARS-CoV-2, influenza A and influenza B, and is not intended to detect influenza C antigens.

All negative results are presumptive and do not rule out influenza or SARS-CoV-2 infection. Negative results should not be used as the sole basis for treatment or patient management decisions.

The Status™ COVID-19/Flu A&B is intended for use by medical professionals or trained operators who are proficient in performing tests in point of care settings.

Important Notes
  • Product is non-returnable; please make sure it is the right product before ordering.
  • For In Vitro Diagnostic Use
  • For Use Under Emergency Use Authorization (EUA) Only
  • For more information on this product's EUA, please go to the EUA section below.
For the State of California:
Warning: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

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Rally #196-1-3225
Manufacturer #33225
BrandStatus
ManufacturerLifeSign / Princeton BioMeditech
Country of OriginUnited States
ApplicationRespiratory Test Kit
Number of Tests25 Tests
Reading TypeVisual Read
Sample TypeAnterior Nasal or Nasopharyngeal Swab Sample
SpecialtyImmunoassay
Test FormatTest Device Format
Test Kit TypeRapid
Test MethodLateral Flow Immunoassay
Test NameCOVID-19 / Flu A and B
Test TypeAntigen Detection
Time to Results15 Minute Results
UNSPSC Code41116144
Storage Temperature2-30°C (35-86°F)
Type Sensitivity Specificity
COVID-19 - Anterior Nasal 93.8% 100%
COVID-19 - Nasopharyngeal 93.1% 100%
Flu A 91.4% 95.7%
Flu B 87.6% 95.9%

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Configurations
Product ID Description Quantity
33225 Status™ Covid-19/Flu A&B 25 Tests Per Kit
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- Materials Provided -

Each Status™ COVID-19/Flu A&B kit contains enough reagents and materials for 25 tests.
The following components are included in a kit:

  • Status COVID-19/Flu A&B test devices (25): The test strip in each device contains mouse monoclonal antibodies to nucleocapsid protein of influenza A, influenza B and SARS-CoV-2. The device is individually pouched.
  • Extraction Reagent in capsules (25): For use with swab specimens; 300 µL of Phosphate buffer with detergents and preservative
  • Sterile Swabs (25): For swab specimen collection
  • Positive Control Swab (1): Influenza A, B, and SARS-CoV-2 antigen (non-infective recombinant nucleocapsid protein)
  • Negative Control Swab (1): Inactivated Group B Streptococcus antigen (non-infective)
  • Package Insert /Instructions for use (1)
  • Quick Reference Instructions (1)
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EUA - Emergency Use Authorization

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. 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 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.


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