Immunoassay Quality Control ADVIA Centaur IL-6 Level 1, 2, 3 3 X 7 mL
- 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 \n
- 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 \n
- 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 \n
- 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 \n
- For use by health care providers \n
- For prescription use only \n
- For in vitro diagnostic use only \n
- 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 \n
- Results must be combined with clinical observations, patient history, other laboratory parameters, and epidemiological information \n
- Each of 3 vials: After reconstitution, three levels of recombinant human IL-6; bovine serum albumin; preservatives
- Volume:
- 3 x 7 ml
- Mckesson #:
- 1184494
- Levels:
- level 1 2 3
- Manufacturer:
- Siemens Healthcare
- Storage requirements:
- requires refrigeration
- Brand:
- Advia Centaur
- Manufacturer #:
- 10995083
- UNSPSC:
- 41116107
- Form:
- lyophilized
- For use with:
- for use with advia centaur il6 assay on advia centaur xp advia centaur xpt and advia centaur cp systems
- Test name:
- il-6
- Container type:
- vial
- Test type:
- immunoassay
- Product dating:
- mckesson acceptable dating: we will ship >= 90 days
- Application:
- quality control
