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Reagent Kit Lyra® Molecular Diagnostic / Real Time RT-PCR Direct SARS-CoV-2 For use with Thermocycler 96 TestsM943

Reagent-Kit-Lyra®-Molecular-Diagnostic--Real-Time-RT-PCR-Direct-SARS-CoV-2-For-use-with-Thermocycler-96-TestsM943

SKU #

#1177619

MPN #

M943

Brand

Quidel

Stock

In Stock

Quantity

100

Features

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

$5,377.15 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1177619
Manufacturer # M943
Brand Lyra®
Manufacturer Quidel
Application Reagent Kit
Container Type Vial
For Use With For use with Thermocycler
Number of Tests 96 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Sample Type Nasal Swab / Nasopharyngeal Swab / Oropharyngeal Swab Sample
Storage Requirements Requires Refrigeration
Test Name Direct SARS-CoV-2
Test Type Molecular Diagnostic / Real Time RT-PCR
Time To Results 70 Minute Results
UNSPSC Code 41116144
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  • 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
  • Lyra Direct SARS-CoV-2 Assay (Microfuge Format) with Nasopharyngeal Swabs and Transport Tubes includes: 96 tests, 100 Microfuge Tubes (1.5 mL), 100 Swabs, 100 Transport Tubes
  • Simplified and uniform workflow with standard pipetting volumes
  • No ice or cooling block required
  • 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