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Picture of Calibrator Access® SARS-CoV-2 IgG II 6 X 2 mL For use with Access Family of Immunoassay SystemsC69058

Calibrator Access® SARS-CoV-2 IgG II 6 X 2 mL For use with Access Family of Immunoassay SystemsC69058

Calibrator-Access®-SARS-CoV-2-IgG-II-6-X-2-mL-For-use-with-Access-Family-of-Immunoassay-SystemsC69058

SKU #

#1183727

MPN #

C69058

Brand

Beckman Coulter

Stock

In Stock

Quantity

100

Features

CALIBRATOR, ACCESS SARS-COV-2 IGG II CALIBRATOR (1/BX) D/S

$238.40 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1183727
Manufacturer # C69058
Brand Access®
Manufacturer Beckman Coulter
Application Calibrator
Container Type Vial
For Use With For use with Access Family of Immunoassay Systems
Levels 6 Levels
Test Name SARS-CoV-2 IgG II
Test Type Antibody Test
UNSPSC Code 41116128
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, to perform high or moderate complexity tests
  • For U.S.A. only, Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician
  • The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (heparin, EDTA, citrate) for use on the Access Family of Immunoassay Systems only
  • 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
  • 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
  • The Access SARS-CoV-2 IgG II Calibrators are provided at six levels – zero and approximately 5.0, 25.0, 100, 200, and 450 AU/mL