FDA-Device2022-09-07Class II
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
Siemens Healthcare Diagnostics, Inc.
Hazard
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.
Affected count
129 units US; 159 units OUS
Manufactured in
500 Gbc Dr, Newark, DE, United States
Products
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1648-2022Don't want to check this manually?
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