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Germaine™ Laboratories Status™ Covid-19/Flu A & B Rapid Test
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Quantity:
25 Tests
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
Certifications/Compliance | FDA EUA Approved |
Content And Storage | 2° to 30°C (35° to 86°F) |
Control Sets | Includes Positive/Negative Control Swabs |
CE Marker | Yes |
Detectable Analytes | SARS-CoV-2, Influenza A/B Nucleic Acids |
Sample Type | Nucleocapsid Antigen from SARS-CoV2, Influenza A, and Influenza B |
Sensitivity | COVID-19: 93.9%, Flu A: 91.4%, Flu B: 87.6% |
Disposable | Single-use |
Includes | 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) |
Quantity | 25 Tests |
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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.
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