22-321-105

SEKISUI Diagnostics™ OSOM™ Ultra Flu A and B Rapid Test

Manufacturer: Fischer Scientific

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Certifications/Compliance

Cleared for use with multiple viral transport media (VTM) types

CPT Code

Flu A: 87804; Flu B: 87804-59 (modifier used to indicate separate test)

Detectable Analytes

Influenza A and B

Sample Type

Nasal and Nasopharyngeal Swab, Nasal Aspirate/Wash

Type

OSOM Ultra Flu A and B Rapid Test

Specificity

Influenza A: 99.4%, Influenza B: 99% vs PCR

Content And Storage

Room Temperature

Clia Complexity

Waived, Moderate

Format

Kit

Sensitivity

Influenza A: 89.2%, Influenza B: 86.4% vs. PCR

Includes

25 Test Kits

Test Time

10 to 15 min.

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Description

  • Improved Outcomes: Rapid and accurate diagnosis of Influenza enables a choice of antiviral therapy, helps avoid the overuse of antibiotics, and prevents healthcare costs related to unnecessary testing and treatment
  • Patient Experience: Streamlines lab's workflow while reducing patient wait time and unnecessary use of antibiotics
  • For the detection of Influenza type A and type B nucleoprotein antigens Able to meet FDA reclassification standards Multiple specimen types: nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens Cleared for use with multiple viral transport media (VTM) types Accuracy: Influenza A Sensitivity: >90%; Influenza B: >85% vs culture (across multiple sample types) Fast: Obtain positive results in 10 to 15 minutes Flexible: Runs from nasal swab, NP swab as well as nasal aspirate/wash Workflow: approved for use with multiple viral transport media types QC Inside: 2 extra no charge cassettes to the kit OSOM Ultra Flu A and B Control Kit (Cat
  • No
  • 22321114): 5 x positive Flu A/B swabs and 5 x Negative Flu A/B swabs OSOM Ultra Flu A and B Nasopharyngeal Wash/Aspirate Kit (Cat
  • No
  • 22321106): 50 pipets and 5 mL extraction reagent OSOM Ultra Flu A and B Swab Transport Kit (Cat
  • No
  • 22321107): 25 swabs in transport tubes Storage Requirements: Store at room temperature
  • Compliance Meets FDA Reclassification