Qiagen LLC Reagent Kit QIAstat-Dx® Molecular Diagnostic Respiratory SARS-CoV-2 Panel For use with QIAstat-Dx Instrument 6 Tests - KT/1 - 691223-KT
Qiagen LLC Reagent Kit QIAstat-Dx® Molecular Diagnostic Respiratory SARS-CoV-2 Panel For use with QIAstat-Dx Instrument 6 Tests - KT/1 - 691223-KT
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Qiagen LLC Reagent Kit QIAstat-Dx® Molecular Diagnostic Respiratory SARS-CoV-2 Panel For use with...
| Item Id | 1163375 |
| MF Id# | 691223 |
| Brand | QIAstat-Dx® |
| Manufacturer | Qiagen LLC |
| Country of Origin | Unknown |
| Application | Reagent Kit |
| For Use With | For use with QIAstat-Dx Instrument |
| Number of Tests | 6 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 60 days |
| Sample Type | Nasopharyngeal Swab Sample |
| Storage Requirements | USP Controlled Room Temperature |
| Test Format | Cartridge Format |
| Test Name | Respiratory SARS-CoV-2 Panel |
| Test Type | Molecular Diagnostic |
| Time to Results | 67 Minute Results |
| UNSPSC Code | 41116205 |
Features
- QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid test intended for use with QIAstat-Dx system for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids
- For in vitro diagnostic use under Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures
- Multiplex syndromic cartridge detects and differentiates 21 respiratory targets, including SARS-CoV-2 from nasopharyngeal swabs (NPS) eluted in universal transport media (Enterovirus and Rhinovirus are both detected, but not differentiated)
- Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity and moderate complexity tests
- Please review the documents under the More Information tab prior to purchasing
- Link to FDA site: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- All reagents required for the complete execution of a test run are pre-loaded and self-contained in the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge
- Kit includes: (6) Individually packaged cartridges containing all reagents needed for sample preparation and multiplex real-time RTPCR, plus Internal Control, and (6) individually packaged transfer pipettes for dispensing liquid sample into the QIAstat-Dx Respiratory SARS-CoV-2 Panel Cartridge
- Intuitive workflow with less than one-minute hands-on time
- All wet and dry reagents onboard and room temperature stable
- Comprehensive qualitative results available in about an hour