QDI

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Device class

Class II (moderate risk)

Regulation

21 CFR 864.1880

Medical specialty

Medical Genetics

Flags

Third-party review eligible

FDA 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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