-
,for, Item ID-
- #1184489
- Siemens #11417770
General Chemistry Reagent Dimension® EXL™ SARS-CoV-2 IgG For Dimension EXL Integrated Chemistry System with LOCI Module 480 Tests
REAGENT, DIMENSION CV2G ASSAY (480TEST/KT) D/S
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Features
- The Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) assay 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
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
- The Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) assay is a chemiluminescent immunoassay intended for qualitative and semiquantitative detection of IgG antibodies to SARS‑CoV‑2 in human serum and plasma (dipotassium EDTA and lithium heparin) using the Dimension® EXL™ integrated chemistry system with LOCI® Module
- More …
Product Details Email
Product Specifications
McKesson # | 1184489 |
---|---|
Manufacturer # | 11417770 |
Brand | Dimension® EXL™ |
Manufacturer | Siemens |
Country of Origin | United States |
Application | General Chemistry Reagent |
For Use With | For Dimension EXL Integrated Chemistry System with LOCI Module |
Form | Liquid |
Number of Tests | 480 Tests |
Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
Sample Type | Serum / Plasma Sample |
Specialty | General Chemistry |
Storage Requirements | Requires Refrigeration |
Test Category | Respiratory |
Test Format | Cartridge |
Test Method | Chemiluminescent Immunoassay |
Test Name | SARS-CoV-2 IgG |
Test Type | Antibody Test |
UNSPSC Code | 41116010 |
Features
- The Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) assay 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
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
- The Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) assay is a chemiluminescent immunoassay intended for qualitative and semiquantitative detection of IgG antibodies to SARS‑CoV‑2 in human serum and plasma (dipotassium EDTA and lithium heparin) using the Dimension® EXL™ integrated chemistry system with LOCI® Module
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
- The sensitivity of the Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) assay early after infection is unknown
- 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 the Dimension® EXL™ SARS‑CoV‑2 IgG (CV2G) assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
- Results are for the detection of SARS‑CoV‑2 IgG antibodies; IgG antibodies to SARS‑CoV‑2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post‑infection is not well characterized
- Dimension EXL CV2G Flex Reagent Cartridge: 8 X 60 Tests
More Information
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