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U.S. Department of Health and Human Services

Product Classification

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Device fish based detection of chromosomal abnormalities from patients with hematologic malignancies
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.
Physical State The test kits may include fluorescence labeled DNA probes, hybridization buffers, and a counterstain
Technical Method Fluorescence in situ hybridization
Target Area Human bone marrow and peripheral blood specimens
Regulation Medical Specialty Molecular Genetics
Review Panel Pathology
Product CodeQDI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.1880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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