23-043-081

Quidel Sofia™ RSV FIA Immunofluorescence Kit

Manufacturer: Fischer Scientific

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Clia Complexity

Waived

Sample Type

Nasopharyngeal swab and nasopharyngeal aspirate/wash specimens

For Use With (Application)

IVD

Quantity

3 x 25 Tests

Detectable Analytes

Respiratory Syncytial Virus (RSV) Antigen

Type

Sofia™ RSV FIA Immunofluorescence Test Kit

Includes

Individually packaged cassettes 25, reagent tubes 25, reagent solution 25, sterile nasopharyngeal swabs 25, large, pink fixed volume pipettes 25, small, clear fixed volume pipettes 25, RSV positive control swab 1, negative control swab 1, package insert 1, quick reference instructions 1, QC card, printer Paper 1

Test Time

>15 min.

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Description

  • Use with Sofia Analyzer only Test nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients less than 19 years of age When run in conjunction with Sofia Influenza A+B FIA, a single specimen may be used for both tests Accurate results within 15 mins
  • 25 tests per kit Applications:   IVD CLIA Complexity: This test is CLIA moderately complex for pediatric patients 7 to less than 19 years of age
  • It is CLIA waived for children less than 7 years of age
  • Certifications CE Marked; CLIA Complexity: Waived