-
,for, Item ID-
- #1211934
- Siemens #11208048
Calibrator Set Atellica® IM SARS-CoV-2 Antigen 4 X 1 mL For Calibrating the Atellica IM CoV2Ag Assay using an Atellica Immunoassay Analyzers
CALIBRATOR, IM SARS-COV-2 ANTIGEN ATELLICA (2-HI 2-LO) D/S
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Features
- The Atellica® IM SARS-CoV-2 Antigen (CoV2Ag) assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-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 the requirements to perform moderate or high complexity tests
- The Atellica IM SARS-CoV-2 Antigen (CoV2Ag) assay does not differentiate between SARS-CoV and SARS-CoV-2
- More …
Product Details Email
Product Specifications
McKesson # | 1211934 |
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Manufacturer # | 11208048 |
Brand | Atellica® IM |
Manufacturer | Siemens |
Country of Origin | United States |
Application | Calibrator Set |
Container Type | Vial |
For Use With | For Calibrating the Atellica IM CoV2Ag Assay using an Atellica Immunoassay Analyzers |
Form | Frozen Liquid |
Levels | Low Level / High Level |
Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
Specialty | Immunoassay |
Storage Requirements | Keep Frozen |
Test Category | Respiratory |
Test Name | SARS-CoV-2 Antigen |
Test Type | Antigen Detection |
UNSPSC Code | 41116128 |
Volume | 4 X 1 mL |
Features
- The Atellica® IM SARS-CoV-2 Antigen (CoV2Ag) assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-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 the requirements to perform moderate or high complexity tests
- The Atellica IM SARS-CoV-2 Antigen (CoV2Ag) assay does not differentiate between SARS-CoV and SARS-CoV-2
- Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
- Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed; negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19
- Kit contains: 2 x 1.0 mL low calibrator, 2 x 1.0 mL high calibrator and calibrator lot-specific value sheet
- For Use Under Emergency Use Authorization Only
- For in vitro diagnostic use
- For Prescription Use
- For Professional Use
More Information
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