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PDO — Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization Class II

FDA Device Classification

Classification Details

Product Code
PDO
Device Class
Class II
Regulation Number
864.1870
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Definition

The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or myelodysplastic syndrome. The assay results are to be interpreted by a qualified pathologist or cytogeneticist.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN130010abbott molecularVYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)July 29, 2013