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U.S. Department of Health and Human Services

Product Classification

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Device fluorescence in situ hybridization, chromosome 17p deletion (tp53)
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).
Physical State Probe Kit consists of slide preparation materials, fluorescent FISH probes, buffers and nuclear counterstain, followed by manual signal enumeration using a fluorescence-enabled microscope.
Technical Method The assay uses fluorescence in situ hybridization to identify a deletion in chromosome 17 at the TP53 gene locus in peripheral blood from CLL Patients.
Target Area Peripheral blood
Review Panel Molecular Genetics
Product CodePNK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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