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Germaine™ Laboratories Status™ Covid-19/Flu A & B Rapid Test

A rapid, lateral flow immunoassay intended for the in-vitro simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV- 2, Influenza A, and Influenza B directly from nasopharyngeal swab specimens. The Status COVID-19/Flu Test is only for use under FDA EUA.

Supplier:  Germaine™ Laboratories 33225

Catalog No. 23-111-399


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Description

Description

  • 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
  • 25 individually pouched test devices
  • 1 test + 1 specimen = 3 Results
  • Results in 15 minutes
  • Made in USA

Includes

  • Extraction Reagent Capsules (25): 300 μL of phosphate buffer with detergents and preservative, for use with swab specimens
  • Sterile Swabs (25): For 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 Instruction (1)
Specifications

Specifications

FDA EUA Approved
Includes Positive/Negative Control Swabs
SARS-CoV-2, Influenza A/B Nucleic Acids
COVID-19: 93.9%, Flu A: 91.4%, Flu B: 87.6%
Rapid Test Devices (25), Sterile Swabs (25), Positive Control Swab (1), Negative Control Swab (1), Package Insert/Instructions for Use (1), Quick Reference Instruction (1)
COVID-19: 100%, Flu A: 95.7%, Flu B: 95.9%
15 min.
2° to 30°C (35° to 86°F)
Yes
Nucleocapsid Antigen from SARS-CoV2, Influenza A, and Influenza B
Single-use
25 Tests
Non-sterile
Safety and Handling

Safety and Handling

ShelfLife : 8 Months from DOM

SDS
Documents

Documents

Product Certifications
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The Status COVID-19/Flu test is only for use under FDA EUA. 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.