Beckman Coulter Antibody Test Quality Control Access® SARS-CoV-2 IgG II 2 Levels 6 X 4 mL - Box o...
| Item Id | 1183728 |
| MF Id# | C69059 |
| Brand | Access® |
| Manufacturer | Beckman Coulter |
| Country of Origin | United States |
| Application | Quality Control |
| Container Type | Vial |
| For Use With | For Monitoring System Performance of the Access SARS-CoV-2 IgG II Assay using the Access Immunoassay Systems only |
| Levels | 2 Levels |
| Test Name | SARS-CoV-2 IgG II |
| Test Type | Antibody Test |
| UNSPSC Code | 41116128 |
| Volume | 6 X 4 mL |
Features
- This test has not been reviewed by the FDA
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high or moderate complexity tests
- For U.S.A. only, Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician
- 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 acute SARS-CoV-2 infection
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
- QC1-QC2, 4 mL/vial, 3 vials each level