NRSClass II

Control Material, Blood Circulating Epithelial Cancer Cell

Hematology · 21 CFR 864.8625

The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.

MDR events0All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances1All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Veridex, LLC
TerminatedMar 1, 2011
Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.
Z-1472-2011 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Veridex, LLCJun 28, 2004
K040898 · CELLSEARCH EPITHELIAL CELL CONTROL KIT