Dna-Probe Kit, Human Chromosome
The DNA-Probe Kit, Human Chromosome is an in vitro diagnostic FISH probe kit intended to detect alpha satellite sequences in the centromere regions of human chromosomes as an adjunct to standard cytogenetic metaphase analysis, used for identifying and enumerating human chromosomes in metaphase cells and interphase nuclei; results must be interpreted in conjunction with standard cytogenetic analysis. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OYU, with regulation number 866.4700 under the Immunology specialty, reviewed by the pathology panel.
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Basic Information
- Product Code
- OYU
- Device Class
- FDA class 2
- Regulation Number
- 866.4700
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.