Siemens Immunoassay Reagent Atellica® IM Antibody Test SARS-CoV-2 IgG For Atellica IM Analyzer 100 Tests 40 µL Sample Volume - KT/1 - 11207386-KT
Siemens Immunoassay Reagent Atellica® IM Antibody Test SARS-CoV-2 IgG For Atellica IM Analyzer 100 Tests 40 µL Sample Volume - KT/1 - 11207386-KT
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50 In stock
Estimated deliver: Jan23 - Jan26
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Siemens Immunoassay Reagent Atellica® IM Antibody Test SARS-CoV-2 IgG For Atellica IM Analyzer 10...
| Item Id | 1192763 |
| MF Id# | 11207386 |
| Brand | Atellica® IM |
| Manufacturer | Siemens |
| Country of Origin | United States |
| Application | Immunoassay Reagent |
| Container Type | Vial |
| For Use With | For Atellica IM Analyzer |
| Is_Active_Vendor | Y |
| Is_DSCSA | N |
| Is_Discontinued | N |
| Is_Medical_Device | N |
| Lot_Tracking_Flag | N |
| Number of Tests | 100 Tests |
| On_Allocation | N |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Sample Type | Serum / Plasma Sample |
| Storage Requirements | Requires Refrigeration |
| Supplier_ID | 3849247 |
| Test Method | Chemiluminescent Immunoassay |
| Test Name | SARS-CoV-2 IgG |
| Test Type | Antibody Test |
| Time to Results | 25 Minute Time to First Result |
| UNSPSC Code | 41116004 |
| Volume | 40 µL Sample Volume |
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
- Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains
- The Atellica® IM SARS-CoV-2 IgG (sCOVG) assay is a chemiluminescent immunoassay intended for the qualitative and semi-quantitative detection of IgG antibodies, including neutralizing antibodies, to SARS-CoV-2 in human serum and plasma (lithium heparin) using the Atellica® IM Analyzer
- Contents: 1 ReadyPack primary reagent pack containing Atellica sCOVG Lite Reagent, Solid Phase, and Ancillary Well Reagent, 1 ReadyPack ancillary reagent pack containing Atellica sCOVG DIL, Atellica IM sCOVG master curve and test definition, 1 vial sCOVG low calibrator, 1 vial sCOVG high calibrator, sCOVG calibrator assigned value sheet
- Results from antibody testing should not be used to diagnose or exclude acute SARSCoV-2 infection