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ImmunoCard STAT! FLU A&B

782030 · Meridian Bioscience, Inc.

ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.

Details

Device typeInfluenza A/B virus antigen IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from influenza A virus and/or influenza B virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

FDA categoryDevices Detecting Influenza A, B, And C Virus Antigens

Device ID00840733101656

Catalog number782030

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone(513) 271-3700

Emailinfo@meridianbioscience.com

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