OYU — Dna-Probe Kit, Human Chromosome Class II

FDA Device Classification

Classification Details

Product Code
OYU
Device Class
Class II
Regulation Number
866.4700
Submission Type
Review Panel
PA
Medical Specialty
Immunology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K010288vysisANEUVYSION MULITICOLOR DNA PROBE KITApril 13, 2001
K972200vysisANEUVYSIONOctober 20, 1997
K953591vysisCEP 8 SPECTRUMORANGE DNA PROBE KITNovember 29, 1996