Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

PDO · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.1870

Classification

FDA Product Code: PDO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.1870
Review panel: PA
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown