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Molecular Diagnostic Control SARS-CoV-2 Positive LevelM5301

Molecular-Diagnostic-Control-SARS-CoV-2-Positive-LevelM5301

SKU #

#1182303

MPN #

M5301

Brand

Quidel

Stock

In Stock

Quantity

100

Features

CONTROL, SOLANA SARS-COV -2 POS D/S

$143.04 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1182303
Manufacturer # M5301
Manufacturer Quidel
Application Control
For Use With For use with Solana SARS-CoV-2 Assay on the Solana Instrument
Levels Positive Level
Product Dating McKesson Acceptable Dating: we will ship >= 30 days
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2
Test Type Molecular Diagnostic
UNSPSC Code 41116145
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  • Solana SARS-CoV-2 Assay is for use under an FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high or moderate complexity tests
  • The Solana SARS-CoV-2 Assay is an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens from individuals 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
  • Laboratories within the United States and its territories are required to report all 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 Solana SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Solana SARS-CoV-2 Assay and/or the Solana Instrument
  • The external positive control (containing SARS-CoV-2 Synthetic RNA) may be treated as a patient specimen
  • The external positive control is intended to monitor substantial reagent and instrument failure