NRS — Control Material, Blood Circulating Epithelial Cancer Cell Class II
FDA product code NRS covers "Control Material, Blood Circulating Epithelial Cancer Cell", a Class II medical device regulated under 21 CFR 864.8625. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
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 |