FDA-Device2018-05-16Class II
ADVIA Centaur¿ HBc IgM
Siemens Healthcare Diagnostics, Inc.
Hazard
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Sold states
Nationwide and Canada, Mexico, and Thailand
Affected count
6
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
ADVIA Centaur¿ HBc IgM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2018Don't want to check this manually?
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