Control Material, Blood Circulating Epithelial Cancer Cell
Device Code: 2429
Product Code(s):
NRS 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 E
Device Classification Information
| Device Type ID | 2429 |
| Device Name | Control Material, Blood Circulating Epithelial Cancer Cell |
| Regulation Description | Hematology Quality Control Mixture. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.8625 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NRS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 2429 |
| Device | Control Material, Blood Circulating Epithelial Cancer Cell |
| Product Code | NRS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hematology Quality Control Mixture. |
| CFR Regulation Number | 864.8625 [🔎] |
TPLC Last Update: 2019-04-02 20:11:52