Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)

* The Healgen® COVID-19/Flu A&B Ag Combo Rapid test Cassette (Swab) 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.

** Swabbing should be performed by an adult for children aged 2 to 13. User must be aged 14 + to perform self test.

	INTENDED USE: For the qualitative detection and differentiation of SARS-CoV-2, Influenza A and B antigens directly from anterior nasal swab specimens. Please see the Instructions for Use for the full intended use.
	ACCURACY: SARS-CoV-2 : PPA 92.0%, NPA 99.0%, Influenza A : PPA 92.5%, NPA 99.9%, Influenza B : PPA 90.5%, NPA 99.9%
	CPT code: 87428-QW
	Shelf life: 16 months
	Storage conditions: 2-30°C/36-86°F

Healgen® COVID-19/Flu A&B Ag Combo
Rapid Test Cassette (Swab)

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For Emergency Use Authorization (EUA) Only* | For in vitro diagnostic use | For Prescription Use Only

Why Choose Healgen® COVID-19/Flu A&B Ag Combo Rapid Test:

Product Specifications

Test Procedure

Ordering Information

	SUPERIOR PERFORMANCE: Comparator method RT-PCR
	SIMPLE TO USE: Minimal training required