Dna-probe Kit, Human Chromosome
Device Code: 3093
Product Code(s):
OYU 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 Enume
Device Classification Information
| Device Type ID | 3093 |
| Device Name | Dna-probe Kit, Human Chromosome |
| Physical State | Reagents For Identifying And Enumerating Human Chromosomes |
| Technical Method | Fluorescence In Situ Hybridization (FISH) |
| Target Area | Human Cells |
| Regulation Description | Automated Fluorescence In Situ Hybridization (FISH) Enumeration Systems. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.4700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OYU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3093 |
| Device | Dna-probe Kit, Human Chromosome |
| Product Code | OYU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Fluorescence In Situ Hybridization (FISH) Enumeration Systems. |
| CFR Regulation Number | 866.4700 [🔎] |
TPLC Last Update: 2019-04-02 20:23:43