OYU

3 FDA 510(k) clearances · Product code

FDA profile

Official device name

Dna-Probe Kit, Human Chromosome

Device class

Class II (moderate risk)

Regulation

21 CFR 866.4700

Medical specialty

Immunology

FDA 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.

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