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Picture of Calibrator Access® SARS-CoV-2 IgG (1st IS) 6 X 2 mL For use on Access Family of Immunoassay SystemsC74340

Calibrator Access® SARS-CoV-2 IgG (1st IS) 6 X 2 mL For use on Access Family of Immunoassay SystemsC74340

Calibrator-Access®-SARS-CoV-2-IgG-(1st-IS)-6-X-2-mL-For-use-on-Access-Family-of-Immunoassay-SystemsC74340

SKU #

#1193452

MPN #

C74340

Brand

Beckman Coulter

Stock

In Stock

Quantity

100

Features

CALIBRATOR, ACCESS SARS-COV-2 IGG 2X2ML D/S

$238.40 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1193452
Manufacturer # C74340
Brand Access®
Manufacturer Beckman Coulter
Application Calibrator
Container Type Vial
For Use With For use on Access Family of Immunoassay Systems
Levels Level S0, S1, S2, S3, S4, S5
Test Name SARS-CoV-2 IgG (1st IS)
Test Type Antibody Test
Volume 6 X 2 mL
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  • This test has not been reviewed by the FDA
  • 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 high complexity tests
  • Intended to calibrate the Access SARS-CoV-2 IgG (1st IS) assay for the in vitro quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (heparin, EDTA and citrate) for use on the Access Family of Immunoassay Systems
  • The Access SARS-CoV-2 IgG (1st IS) assay is a paramagnetic particle, chemiluminescent immunoassay intended for the quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (heparin, EDTA and citrate)
  • The Access SARS-CoV-2 IgG (1st IS) 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
  • Laboratories within the United States and its territories are required to report all 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
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
  • Access SARS-CoV-2 IgG (1st IS) test is to be used with the fully automated Access Family of Immunoassay Analyzers including the standalone Access 2, UniCel DxI 600, and UniCel 800 analyzers and integrated chemistry/immunoassay platforms; UniCel DxC 600i, UniCel DxC 680i, UniCel DxC 880i, UniCel DxC 660i and UniCel DxC 860
  • The analyte in the Access SARS-CoV-2 IgG (1st IS) Calibrators are traceable to the First WHO International Standard Anti-SARS-CoV-2 Immunoglobulin (Human), NIBSC code, 20/136
  • Provided ready to use