Rapid Test Kit Healgen® Ag Combo Rapid Test Antigen Detection COVID-19 / Flu A and B Nasopharyngeal Swab Sample 25 Tests (25/KT 20KT/CS) by Healgen Scientific LLC ID GCFC-525Sa

Rally #188-1-5252
Healgen Scientific #GCFC-525Sa
Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (25/KT 20KT/CS)
Respiratory Test Kit, SARS-COV-2/FLU A+B, Lateral Flow Immunochromatographic Assay, Anterior Nasal Swab, Rx Only

Features

• Detect 3 viruses at once (SARS-CoV-2, Flu A&B)
• For symptomatic individuals within 5 days of symptom onset
• Shallow nasal swab sample collection
• Suitable for 2+ years old

Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test 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.

Results are for the in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus protein antigens, but do not differentiate, between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens.

All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out influenza or SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.

Important Note:

• Product is non-returnable; please make sure it is the right product before ordering.
• If put into refrigeration, do not freeze.
• For in vitro diagnostic use.
• Reagent and devices must be used at room temperature (59-89 °F / 2-30 °C).
• The unsealed cassette is only valid for 1 hour.
• Swabbing should be performed by an adult for children aged 2 to 13.
• User must be aged 14 + to perform self test.
• For use under an Emergency Use Authorization (EUA) only.
• For more information on this product's EUA, please go to the EUA section below.

Shelf Life Extension Notice: The shelf life expiration date of Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette have been extended to 18 months. Documentation regarding this extension can be found in the Education & Documents section. Please note that the shelf life expiration date for the controls of this product have not been extented.

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.