Beckman Coulter Immunoassay Reagent Access® IL-6 For Access Immunoassay Systems 2 X 50 Tests 2 X 50 mL - Each - A30945-EA

REAGENT, ACCESS IL 6 2X50ML D/S Item Id 1131782 MF Id# A30945 Brand Access® Manufacturer...


Beckman Coulter

A30945-EA

50 In Stock Sold Out 50



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REAGENT, ACCESS IL 6 2X50ML D/S

Item Id 1131782
MF Id# A30945
Brand Access®
Manufacturer Beckman Coulter
Country of Origin United States
Application Immunoassay Reagent
Container Type Bottle
For Use With For Access Immunoassay Systems
Is_Active_Vendor Y
Is_DSCSA N
Is_Discontinued N
Is_Medical_Device N
Lot_Tracking_Flag N
Number of Tests 2 X 50 Tests
On_Allocation N
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Sample Type Serum / Plasma Sample
Storage Requirements Requires Refrigeration
Supplier_ID 488041
Test Method Chemiluminescent Immunoassay
Test Name IL-6
Time to Results 35 Minute Results
UNSPSC Code 41116004
Volume 2 X 50 mL

Features

  • 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
  • The Access IL-6 assay is a paramagnetic particle, chemiluminescent immunoassay and is intended for use on Access immunoassay analyzers
  • Approx 35 Minutes time to first result
  • 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
  • WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov.