PNK — Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) Class III
FDA product code PNK covers "Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PNK
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- MG
- Medical Specialty
- Unknown
- Implant
- No
Definition
A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).