Siemens Antibody Test Quality Control Kit Atellica® IM SARS-CoV-2 IgG Positive Level / Negative L...
| Item Id | 1185715 |
| MF Id# | 11207388 |
| Brand | Atellica® IM |
| Manufacturer | Siemens |
| Country of Origin | United States |
| Application | Quality Control Kit |
| Container Type | Vial |
| For Use With | For Monitoring Precision and Accuracy of the Atellica® IM SARS-CoV-2 IgG (sCOVG) Assay using the Atellica® IM Analyzer |
| Form | Liquid |
| Is_Active_Vendor | Y |
| Is_DSCSA | N |
| Is_Discontinued | N |
| Is_Medical_Device | N |
| Levels | Positive Level / Negative Level |
| Lot_Tracking_Flag | N |
| On_Allocation | N |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Storage Requirements | Requires Refrigeration |
| Supplier_ID | 3849247 |
| Test Name | SARS-CoV-2 IgG |
| Test Type | Antibody Test |
| UNSPSC Code | 41116145 |
| Volume | 2 X 2 X 2 mL |
Features
- The Atellica IM SARS-CoV-2 IgG is for use under Emergency Use Authorization Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2
- Testing is limited to 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
- The Atellica® IM SARS-CoV-2 IgG Quality Control (sCOVG QC) is for in vitro diagnostic use in monitoring the precision and accuracy of the Atellica® IM SARS-CoV-2 IgG (sCOVG) assay using the Atellica® IM Analyzer
- Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
- Results from antibody testing should not be used to diagnose or exclude acute SARSCoV-2 infection
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
- 2 vials x 2.0 mL negative control, 2 vials x 2.0 mL positive control
- Quality control materials are liquid and ready to use