Name: Healgen™ SARS-CoV-2/Flu A+B Rapid Antigen Test
Brand: Healgen
SKU: GCFC-525Sa
Price: 111.25 USD
Availability: InStock

Healgen™ SARS-CoV-2/Flu A+B Rapid Antigen Test

$111.25 USD

Healgen™ SARS-CoV-2/Flu A+B Rapid Antigen Test

$111.25 USD $4.45 USD each

NOTE: Interested in buying a larger quantity? Please contact us at info@summitmedpartners.com for pricing.

Lateral flow immunoassay for simultaneous detection of SARS-CoV-2, Influenza A, and Influenza B antigens using anterior nasal swab samples. Results within 15 minutes. COVID-19: 92.0% sensitivity, 99.0% specificity. Flu A: 92.5% sensitivity, 99.9% specificity. Flu B: 90.5% sensitivity, 99.9% specificity. CLIA Waived. No equipment required. Includes 25 test cassettes, 25 sterile nasal swabs, 25 prefilled extraction buffer tubes, 25 extraction tube tips, and tube holder. 25 tests per box.

Healgen Rapid Check SARS-CoV-2/Flu A+B Rapid Antigen Point-of-Care Test is a lateral flow immunoassay intended for in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from anterior nasal swab specimens obtained from patients who are suspected of COVID-19 by their healthcare provider, within the first five days of onset of symptoms.

Features and Benefits:

SARS-CoV-2/Flu A+B Rapid POC Combo Antigen Test
Simultaneous testing for acute respiratory infections caused by COVID-19, Flu A, Flu B
Lateral flow immunoassay
Covid-19: Sensitivity 92.0%; Specificity 99.0%
Flu A: Sensitivity 92.5%; Specificity 99.9%
Flu B: Sensitivity 90.5%; Specificity 99.9%
Nasal swab samples
Delivers results within 15 minutes
No equipment necessary
CLIA Waived Test

Authorized Laboratories:

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 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.

Disclaimer:

"For Emergency Use Authorization (EUA) only*. For in vitro diagnostic use. For Prescription Use Only.

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."

Box Includes: