Product code OYU

Device name
Dna-Probe Kit, Human Chromosome
Medical specialty
Immunology
Device class
2
Regulation number
866.4700
Review panel
PA
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset