NRS — Control Material, Blood Circulating Epithelial Cancer Cell Class II
Classification Details
- Product Code
- NRS
- Device Class
- Class II
- Regulation Number
- 864.8625
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K040898 | veridex | CELLSEARCH EPITHELIAL CELL CONTROL KIT | June 28, 2004 |