Roche Real Time RT-PCR Molecular Control Kit Cobas® SARS-CoV-2 Positive Level / Negative Level 3 ...
| Item Id | 1194866 |
| MF Id# | 09408835190 |
| Brand | Cobas® |
| Manufacturer | Roche |
| Country of Origin | United States |
| Application | Molecular Control Kit |
| Container Type | Tube |
| For Use With | For Evaluation of the Performance of Nucleic Acid Tests for Determination of Presence of SARS-CoV-2 on the cobas® Liat® Analyzer |
| Levels | Positive Level / Negative Level |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Storage Requirements | Requires Refrigeration |
| Test Name | SARS-CoV-2 |
| Test Type | Real Time RT-PCR |
| UNSPSC Code | 41116145 |
| Volume | 3 X 0.25 mL / 3 X 0.3 mL |
Features
- cobas® SARS-CoV-2 is for use under the Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
- cobas® SARS-CoV-2 is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- In the United States (US), testing with cobas® SARS-CoV-2 is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests
- Positive results are indicative of the presence of SARS-CoV-2 RNA
- Positive results do not rule out bacterial infection or co-infection with other viruses; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
- Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions
- Negative results must be combined with clinical observations, patient history, and/or epidemiological information
- cobas® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas Liat System
- Laboratories within the U.S. and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
- Kit includes: 8 Transfer Pipettes, 1 control kit barcode card, 3 X 0.25 mL Positive Control, 3 X 0.3 mL Dilution UTM
- Requires: cobas® Liat® Analyzer (P/N 07341920190) including cobas® Liat® System Software (Core) Version 3.3 or higher and cobas® SARS CoV-2 Assay Script v1.0 or higher