Product code PDO— Hematology

VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)

Classification name: Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
Device class: Class 2
Regulation: 21 CFR 864.1870
Advisory panel: Hematology
Total cleared: 1
First cleared: 2013-07-29
Most recent: 2013-07-29

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code PDO under 21 CFR 864.1870, via openFDA

Market context for product code PDO

FDA has cleared 1 device under product code PDO, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PDO

Abbott Molecular, Inc.1 clearance

Recent clearances under product code PDO

DEN130010 — VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)Abbott Molecular, Inc.·2013-07-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.