Home / Clinical Laboratory / Controls / Quality Control / Immunoassay Quality Control Access® IL-6 Positive Level / Negative Level 4 X 2.5 mLA30946
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Immunoassay Quality Control Access® IL-6 Positive Level / Negative Level 4 X 2.5 mLA30946

Immunoassay-Quality-Control-Access®-IL-6-Positive-Level--Negative-Level-4-X-2-5-mLA30946

SKU #

#1131786

MPN #

A30946

Brand

Beckman Coulter

Stock

In Stock

Quantity

100

Features

REAGENT, ACCESS IL 6 QC D/S

$417.19 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1131786
Manufacturer # A30946
Brand Access®
Manufacturer Beckman Coulter
Application Quality Control
Container Type Vial
For Use With For use with Access IL-6 Assay on Family of Immunoassay Systems
Levels Positive Level / Negative Level
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Keep Frozen
Test Name IL-6
Test Type Immunoassay
UNSPSC Code 41116004
Volume 4 X 2.5 mL
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  • The Access IL-6 Immunoassay is only for use under the Food and Drug Administration’s Emergency Use: 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 of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests
  • This test has been authorized only to assist in identifying severe inflammatory response, when used as an aid in determining the risk of intubation with mechanical ventilation in confirmed COVID-19 patients
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner
  • The Access IL-6 assay is an in vitro diagnostic test for the quantitative measurement of IL-6 (Interleukin 6) in human serum and plasma (heparin)
  • Normal IL-6 results do not preclude development of a severe inflammatory response, and IL-6 should not be used as the sole basis for patient management decision
  • Results must be combined with clinical observations, patient history, other laboratory parameters, and epidemiological information
  • For use with Access Family of Immunoassay Systems: Access 2, UniCel DxC 600i, UniCel DxI 600, UniCel DxI 800, UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, UniCel DxC 660i