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U.S. Department of Health and Human Services

Product Classification
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Device dna fish probe kit for specimen characterization, human chromosome, hematological disorders
Regulation Description Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
Definition DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.
Physical State DNA probes labeled with fluorescent dyes, hybridization buffers, counterstain
Technical Method Cells from bone marrow or peripheral blood are obtained from a patient with a hematological disorder. Cells are attached to microscope slides using standard cytogenetic procedures. The resulting specimen DNA is denatured to single-stranded form and subsequently allowed to hybridize with ore or more fluorescently labeled DNA probes. Following hybridization, the unbound probe is removed by a series of washes, and the nuclei are counterstained with I, a DNA-specific stain that fluoresces blue. Hybridization of the probe(s) is viewed using a fluorescence microscope equipped with appropriate excitation and emission filters, allowing visualization of the fluorescent signals.
Target Area Bone marrow and/or peripheral blood specimens
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodePFG
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 864.1870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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