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Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
Unknown Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PNK

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Class 3

21 CFR

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Unknown

Device Characteristics

No

No

No

Not Eligible

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).