• #1177621
  • Quidel #M945

Reagent Kit Lyra® Molecular Diagnostic / Real Time RT-PCR Direct SARS-CoV-2 For use with Thermocycler 96 Tests

REAGENT, SARS COV-2 ASSAY W/CONTROLS (96/EA) D/S

Features
  • The Lyra® Direct SARS-CoV-2 Assay is for in vitro Diagnostic use under Emergency Use Authorization only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • The Lyra® Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests
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Product Specifications

McKesson #1177621
Manufacturer #M945
BrandLyra®
ManufacturerQuidel
Country of OriginUnited States
ApplicationReagent Kit
Container TypeVial
For Use WithFor use with Thermocycler
Number of Tests96 Tests
Sample TypeNasal Swab / Nasopharyngeal Swab / Oropharyngeal Swab Sample
Storage RequirementsRequires Refrigeration
Test NameDirect SARS-CoV-2
Test TypeMolecular Diagnostic / Real Time RT-PCR
Time To Results70 Minute Results
UNSPSC Code41116144
Features
  • The Lyra® Direct SARS-CoV-2 Assay is for in vitro Diagnostic use under Emergency Use Authorization only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • The Lyra® Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests
  • Positive results do not rule out bacterial infection or co-infection with other viruses
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions
  • Negative results must be combined with clinical observations, patient history, and epidemiological information
  • The Lyra Direct SARS-CoV-2 Assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures
  • Rehydration solution is simply added to the lyophilized Master Mix
  • Results in less than 70 minutes after extraction
  • Simplified and uniform workflow with standard pipetting volumes
  • No ice or cooling block required
  • Lyra Direct SARS-CoV-2 Assay (Microfuge Format) with Nasopharyngeal Swabs and Transport Tubes contains: 96 tests, 96 Deep-well Plate, 100 Swabs, 100 Transport Tubes
  • For use with Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche LightCycler 480, Roche Cobas z480, Qiagen Rotor-Gene Q, Bio-Rad CFX96 Touch, Thermofisher QuantStudio 7 Pro Thermocyclers
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