Immunoassay Quality Control ADVIA Centaur® IL-6 Level 1, 2, 3 3 X 7 mL

Features

• This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA): 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 is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for measurement of IL-6 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 This assay is used to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation
• in conjunction with clinical findings and the results of other laboratory testing For use by health care providers For prescription use only For in vitro diagnostic use only 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 decisions Results must be combined with clinical observations
• patient history
• other laboratory parameters
• and epidemiological information Each of 3 vials: After reconstitution
• three levels of recombinant human IL-6; bovine serum albumin; preservatives