4672513
Quidel Sofia™ RSV FIA Immunofluorescence Kit
For rapid qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigens
Manufacturer: Fischer Scientific
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Clia Complexity
Waived
Sample Type
Nasopharyngeal swab and nasopharyngeal aspirate/wash specimens
For Use With (Application)
IVD
Test Time
>15 min.
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
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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
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Clia Complexity: Waived
Sample Type: Nasopharyngeal swab and nasopharyngeal aspirate/wash specimens
For Use With (Application): IVD
Test Time: >15 min.
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
Clia Complexity:
Waived
Sample Type:
Nasopharyngeal swab and nasopharyngeal aspirate/wash specimens
For Use With (Application):
IVD
Test Time:
>15 min.
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
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