FDA-Device2024-09-18Class II
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:10995489
Siemens Healthcare Diagnostics, Inc.
Hazard
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
Sold states
Worldwide - US Nationwide distribution
Manufactured in
333 Coney St, East Walpole, MA, United States
Products
Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN:10995489
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3101-2024Don't want to check this manually?
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