DeviceClearance

Product code OYU— Immunology

ANEUVYSION

Classification name
Dna-Probe Kit, Human Chromosome
Device class
Class 2
Regulation
21 CFR 866.4700
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

FDA classification definition

“Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen.”

— U.S. Food and Drug Administration, device classification record for product code OYU under 21 CFR 866.4700, via openFDA

Market context for product code OYU

FDA has cleared 3 devices under product code OYU between 1996 and 2001, 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.

Clearances per year

Top applicants under product code OYU

Recent clearances under product code OYU

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