FDA Product Code OYU: Dna-probe Kit, Human Chromosome
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.
3
Total
3
Cleared
230d
Avg days
1996
Since
FDA 510(k) Cleared Dna-probe Kit, Human Chromosome Devices (Product Code OYU)
3 devices
No devices found for this product code.