Home / Clinical Laboratory / Controls / Control / Molecular Diagnostic / Real-Time RT-PCR Control Lyra® SARS-CoV-2 Positivel Level 1 mLM5153
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Molecular Diagnostic / Real-Time RT-PCR Control Lyra® SARS-CoV-2 Positivel Level 1 mLM5153

Molecular-Diagnostic--Real-Time-RT-PCR-Control-Lyra®-SARS-CoV-2-Positivel-Level-1-mLM5153

SKU #

#1177628

MPN #

M5153

Brand

Quidel

Stock

In Stock

Quantity

100

Features

CONTROL, SARS COV-2 LYRA POSITIVE D/S

$16.32 USD

Attribute Name Attribute Value
McKesson # 1177628
Manufacturer # M5153
Brand Lyra®
Manufacturer Quidel
Application Control
Container Type Vial
For Use With For use with Lyra® SARS-CoV-2 Assay
Levels Positivel Level
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2
Test Type Molecular Diagnostic / Real-Time RT-PCR
UNSPSC Code 41116145
Volume 1 mL

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  • Lyra SARS-CoV-2 Assay is authorized 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 for use only under EUA in United States (U.S.) laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests
  • The Lyra SARS-CoV-2 Assay is a qualitative test for the detection of nucleic acid from SARSCoV-2 in NP and OP swab specimens obtained from patients suspected of COVID-19 by their healthcare provider
  • 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 - positive results do not rule out bacterial infection or co-infection with other viruses
  • 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