Home / Clinical Laboratory / Controls / Control / Molecular Diagnostic / Real Time RT-PCR Control Lyra® SARS-CoV-2 Process Control 1 mLM5273
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Molecular Diagnostic / Real Time RT-PCR Control Lyra® SARS-CoV-2 Process Control 1 mLM5273

Molecular-Diagnostic--Real-Time-RT-PCR-Control-Lyra®-SARS-CoV-2-Process-Control-1-mLM5273

SKU #

#1181003

MPN #

M5273

Brand

Quidel

Stock

In Stock

Quantity

100

Features

CONTROL, SARS COV-2 LYRA PROCESS F/M120 1ML D/S

$23.84 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1181003
Manufacturer # M5273
Brand Lyra®
Manufacturer Quidel
Application Control
Container Type Vial
For Use With For use with Lyra® SARS-CoV-2 Assay
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 Process Control
Test Type Molecular Diagnostic / Real Time RT-PCR
UNSPSC Code 41116145
Volume 1 mL
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  • The Lyra SARS-CoV-2 Assay with Controls is for use under an FDA EUA:https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Lyra® 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, nasopharyngeal (NP), or oropharyngeal (OP) swab specimens from patients 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; Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
  • 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 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