Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
PNK · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
PNK
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
MG
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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).