Strep A Sofia FIA Test CLIA Non-Waived (25 Test/ .. . .

188-1-2253
      
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Strep A Sofia FIA Test CLIA Non-Waived (25 Test/KT)
Sold by: KT OF 25

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Rally #188-1-2253
Quidel #20253
Respiratory Test Kit Sofia® Strep A FIA Strep A Test 25 Tests CLIA Non-Waived
TEST KIT, STREP A SOFIA (25/KT)

Features
  • All components included in the kit
  • Fixed volume pipette collects and dispenses correct amount of sample needed for testing
  • For use with Sofia Analyzer
  • CLIA-Moderate
  • Highly sensitive and specific with enhanced assay accuracy
The Sofia Strep A Fluorescent Immunoassay (FIA) uses advanced immunofluorescence–based lateral–flow technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients.

Product Specifications
Manufacturer #20253
BrandSofia® Strep A FIA
ManufacturerQuidel
Country of OriginUnited States
ApplicationRespiratory Test Kit
CLIA ClassificationCLIA Moderate Complexity
CLIA ClassifiedCLIA Non-Waived
Contents 1(25) Individually Packaged Cassettes, (25) Reagent Tubes, (25) Reagent Solution, (25) Fixed Volume Pipettes, Positive Control Swab, Negative Control Swab, Printer Paper, Package Insert
For Use WithFor Sofia® Fluorescent Immunoassay Analyzer
Number of Tests25 Tests
Reading TypeMachine Read
Sample TypeThroat Swab Sample
SpecialtyImmunoassay
Test FormatCassette Format
Test Kit TypeRapid
Test NameStrep A Test
Test TypeFluorescence Immunoassay (FIA)
Time to Results5 Minute Results
UNSPSC Code41116129
Kit storage conditionsRoom temperature (15°C to 30°C/59°F to 86°F)
Internal controlsPositive and negative
Sensitivity90.6%
Specificity96.1%
Shelf life24 months from date of manufacture
Weight (Pounds)0.7



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