CareSmart Point-of-Care Antigen Test. 

 

Delivers results in 10 minutes or less.

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Case Components

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• 640 Tests

• Each Test Includes:

  • 1 Test Device

  • 1 Assay Buffer

  • Extraction Vial and Cap

  • Specimen Collection Swabs

  • 1 Positive and 1 Negative Control Swab

  • Instructions For Use

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• Fact Sheet For Health Care Providers

• Emergency Use Authorization (EUA) Letter

• Fact Sheet For Patients

• Instructions For Use Document

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Note:

• 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, 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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