Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette GCFC-525Sa
Offer Valid Through December 31, 2025 Only
See Details Below
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.
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.
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.
Please see Education & Documents section for more information.
× Reimbursements
This product maybe reimbursable, depending on various factors including current law and policies. Rally Inc. does not handle these reimbursements; instead, each reimbursement is handled solely between you, the customer, and the manufacturer, Healgen Scientific LLC. Rally Inc. does not oversee these reimbursements. To check eligibility and get your reimbursements, please follow the manufacturer's reimbursements instructions.
Below are the reimbursement informations provided by Healgen Scientific as of March 12, 2025:
The CPT code for visually read combination tests that detect COVID-19, Influenza A, and Influenza B typically falls under the following:
87811: Infectious agent antigen detection by immunoassay with direct optical observation; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2 [COVID-19]).
87804: Infectious agent antigen detection by immunoassay with direct optical observation; Influenza.
For a combination test for COVID-19, Influenza A, and B, you would likely report 87811 for COVID-19 and 87804 twice (once each for Influenza A and B) if all three viruses are being detected using an immunoassay with visual reading.
Additional CPT Code Information:
Covid 19 Antigen CPT Code: 87811QW
Test A CPT Code: 87804QW
Test B CPT Code: 87804QW-59
(Note: Modifier QW signifies that a diagnostic lab service is a CLIA-waived test, and the provider performing the test holds a CLIA certificate of waiver.)
Please note that Rally Inc. is not responsible for the accuracy of reimbursement informations provided by the manufacturer. In addition, these information might change as time passes. Please contact Healgen Scientific for the latest reimbursement informations. You can contact them here.
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