Abbott Reagent Kit Alinity i Antibody Test SARS-CoV-2 IgG For use with Alinity™ i System 200 Test...
| Item Id | 1166393 |
| MF Id# | 06R9020 |
| Brand | Alinity i |
| Manufacturer | Abbott |
| Country of Origin | Unknown |
| Application | Reagent Kit |
| Container Type | Vial |
| For Use With | For use with Alinity™ i System |
| Is_Active_Vendor | Y |
| Is_DSCSA | N |
| Is_Discontinued | N |
| Is_Medical_Device | N |
| Lot_Tracking_Flag | N |
| Number of Tests | 200 Tests |
| On_Allocation | N |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Sample Type | Human Serum / Plasma Sample |
| Storage Requirements | Requires Refrigeration |
| Supplier_ID | 4446496 |
| Test Method | Chemiluminescent Microparticle Immunoassay (CMIA) |
| Test Name | SARS-CoV-2 IgG |
| Test Type | Antibody Test |
| UNSPSC Code | 41116020 |
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