Molecular Erythrocyte Typing Test
Device Code: 2507
Product Code(s):
PEP Definition: Molecular Determination Of Allelic Variants That Indicate Erythrocyte Antigen Phenotypes
Device Classification Information
| Device Type ID | 2507 |
| Device Name | Molecular Erythrocyte Typing Test |
| Physical State | Solid |
| Technical Method | Molecular |
| Target Area | DNA |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PEP |
| 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 | 2507 |
| Device | Molecular Erythrocyte Typing Test |
| Product Code | PEP |
| FDA Device Classification | Class 3 Medical Device |
TPLC Last Update: 2019-04-02 20:13:30