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U.S. Department of Health and Human Services

Product Classification
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Device early growth response 1 (egr) fish probe kit
Regulation Description Gene expression profiling test system for breast cancer prognosis.
Definition The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients.
Physical State Device is a kit containing labeled FISH Probes
Technical Method Detection of Early Growth Response Gene (EGR1) by fluorescence in-situ hybridization.
Target Area Not applicable
Regulation Medical Specialty Immunology
Review Panel Pathology
Product CodeOWK
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.6040
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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