Abbott Calibrator Kit Alinity i SARS-CoV-2 IgG For the Calibration of the Alinity i System when u...
| Item Id | 1166394 |
| MF Id# | 06R9001 |
| Brand | Alinity i |
| Manufacturer | Abbott |
| Country of Origin | Unknown |
| Application | Calibrator Kit |
| For Use With | For the Calibration of the Alinity 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 |
| 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 | 41116145 |
Features
- SARS-CoV-2 IgG test for use with Alinity i is only for use under the Food and Drug Administration’s Emergency Use Authorization: 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 SARS CoV-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 SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration’s Emergency Use Authorization
- The SARS-CoV-2 IgG Calibrator Kit is for the calibration of the Alinity i system when used for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (ACD, CPD, CPDA-1, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium citrate, sodium heparin)
- Calibrator contains inactivated, cell-free, human blood-derived material, reactive for anti-SARS-CoV-2 IgG