GenBody COVID-19 Ag Test

* The GenBody COVID-19 Ag has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate, high or waived complexity tests. This product 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. This product has been authorized only for the detection of proteins from SARS-CoV-2, 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.

	INTENDED USE: for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anterior nasal (AN) swab specimens. Please see the Instructions for Use for the full intended use.
	ACCURACY: Sensitivity: 92.31%, Specificity: 99.04%
	CPT CODE: 87811-QW
	SHELF LIFE: 21 months
	STORAGE CONDITIONS: 2-30°C/36-86°F

GenBody COVID-19 Ag

Detection of SARS-CoV-2 Antigen

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For Emergency Use Authorization (EUA) Only* | For In Vitro Diagnostic Use | For Prescription Use Only

Why Choose GenBody Ag Test:

Product Specifications

Test Procedure

Ordering Information

	HIGHLY ACCURATE: Identifies acute SARS-COV-2 infection with high accuracy
	RAPID DETECTION: Delivers accurate results in only 15 minutes
	SIMPLE TO USE: Simple 5-step procedure Minimal training required

	PATIENT FRIENDLY: Painless shallow nasal swab sample collection available
	CONTROLS INCLUDED: Internal built-in control & external controls provided