-
,for, Item ID-
- #1177615
- Quidel #M938
Molecular Reagent Lyra® SARS-CoV-2 For BioMerieux NucliSENS easyMAG System or EMAG System / Thermocycler 96 Tests
REAGENT, SARS COV-2 LYRA ASSAYW/CONTROLS (96/EA) D/S
Features
- The Lyra SARS-CoV-2 Assay 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
- More …
Product Details Email
Product Specifications
McKesson # | 1177615 |
---|---|
Manufacturer # | M938 |
Brand | Lyra® |
Manufacturer | Quidel |
Country of Origin | Unknown |
Application | Molecular Reagent |
Container Type | Vial |
For Use With | For BioMerieux NucliSENS easyMAG System or EMAG System / 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 |
Specialty | Molecular |
Storage Requirements | Requires Refrigeration |
Test Category | Respiratory |
Test Name | SARS-CoV-2 |
Test Type | Real Time RT-PCR |
Time to Results | 75 Minute Results |
UNSPSC Code | 41116144 |
Features
- The Lyra SARS-CoV-2 Assay 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
- Results in less than 75 minutes after extraction
- Simplified and uniform workflow with standard pipetting volumes
- No ice or cooling block required
- Lyra SARS-CoV-2 Assay (Microfuge Format) with Nasopharyngeal Swabs and Transport Tubes includes: 96 tests, one 96-well Deep-well Plate, 100 NP Swabs, 100 Transport Media
- For use with BioMerieux NucliSENS® easyMAG® System or EMAG® System / Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche 100 LightCycler 480, Qiagen Rotor-Gene Q, Bio-Rad CFX96 Touch, Thermofisher QuantStudio 7 Pro Thermocyclers
More Information
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