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Dna-Probe Kit, Human Chromosome

FDA product code OYU · 3 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.4700
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1996-11-29 – 2001-04-13

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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