FDA-Device2015-08-26Class II
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Veridex, LLC
Hazard
Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.
Sold states
Nationwide Distribution.
Affected count
1560 kits
Manufactured in
1001 US Route 202, Raritan, NJ, United States
Products
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2406-2015Don't want to check this manually?
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