Control Material, Blood Circulating Epithelial Cancer Cell
NRS is the FDA product code for Control Material, Blood Circulating Epithelial Cancer Cell, a class II device type, regulated under 21 CFR 864.8625. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- NRS
- Device name
- Control Material, Blood Circulating Epithelial Cancer Cell
- FDA 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.
- Regulation
- 21 CFR 864.8625
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code NRS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2004 | 1 |
Applicants with the most clearances
Product code NRS| Applicant | Clearances |
|---|---|
| Veridex, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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