Abbott Antibody Test Control Kit Abbott SARS-CoV-2 IgG Positive Level / Negative Level 2 X 4 mL
| Item Id | 1164348 |
| MF Id# | 06R8610 |
| Brand | Abbott |
| Manufacturer | Abbott |
| Country of Origin | Ireland |
| Application | Control Kit |
| For Use With | For Estimation of Test Precision and the Detection of Systematic Analytical Deviations of the Architect i System when used for the Qualitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum and Plasma |
| 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 >= 90 days |
| Storage Requirements | Requires Refrigeration |
| Supplier_ID | 4446496 |
| Test Name | SARS-CoV-2 IgG |
| Test Type | Antibody Test |
| UNSPSC Code | 41116128 |
| Volume | 2 X 4 mL |
Features
- For In Vitro use; Rx only
- For use under an Emergency Use Authorization (EUA) Only : https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- The SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection; at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
- The SARSCoV-2 IgG assay should not be used to diagnose acute SARS-CoV-2 infection
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, to perform moderate or high complexity test
- 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
- If acute infection is suspected, direct testing for SARS-CoV-2 is necessary
- False positive results for SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
- The human-sourced materials used in the controls have been tested and found to be reactive for anti-SARS-CoV-2 IgG and nonreactive for HBsAg, HIV-1 RNA or HIV-1 Ag, anti-HIV-1/HIV-2, and anti-HCV
- 1 X 4 mL negative control; 1 X 4 mL positive control