PEP — Molecular Erythrocyte Typing Test Class III
FDA product code PEP covers "Molecular Erythrocyte Typing Test", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PEP
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Unknown
- Implant
- No
Definition
Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes