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Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies is a medical device type in the Medical Genetics 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.

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Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies
Medical Genetics Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

QDI

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Class 2

21 CFR 864.1880

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Medical Genetics

Device Characteristics

No

No

No

Eligible

Definition

Fluorescence In Situ Hybridization (FISH) Test for Hematologic Malignancies is used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies. The test is indicated for the clinical management of patients consistent with World Health Organization (WHO) guidelines and in conjunction with other clinical and diagnostic criteria. The results are to be interpreted by a pathologist or equivalent professional.

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