-
,for, Item ID-
- #1208029
- Quidel #M940
Molecular Reagent Lyra® Direct SARS-CoV-2 For Thermocycler 96 Tests
TEST KIT, LYRA DIRECT SARS-COV-2 +VTM W/TU (96TEST/KT) 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
- Lyra Direct SARS kit includes: Viral Transport Media (VTM) with tubes
- More …
Product Details Email
Product Specifications
McKesson # | 1208029 |
---|---|
Manufacturer # | M940 |
Brand | Lyra® |
Manufacturer | Quidel |
Country of Origin | Unknown |
Application | Molecular Reagent |
For Use With | For Thermocycler |
Number of Tests | 96 Tests |
Sample Type | Nasal Swab / Nasopharyngeal Swab / Oropharyngeal Swab Sample |
Specialty | Molecular |
Storage Requirements | Requires Refrigeration |
Test Category | Respiratory |
Test Format | Tube |
Test Name | Direct SARS-CoV-2 |
Test Type | Real Time RT-PCR |
Time to Results | 70 Minute Results |
UNSPSC Code | 41116205 |
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
- Lyra Direct SARS kit includes: Viral Transport Media (VTM) with tubes
- 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
- 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
More Information
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