Definition: X/Y DNA Probe Kit Is Intended To Detect Alpha Satellite Sequences In The Centromere Of Chromosome (Chr) X And Satellite III DNA At Yq12 Of Chr Y Along With Routine Diagnostic Cytogenetic Testing. It Is Indicated For Use As An Adjunct To Standard Cyto
| Device Type ID | 2466 |
| Device Name | Dna-probe Kit, Human Chromosome X And Y, Bmt Engraftment |
| Physical State | Reagents For Monitoring Engraftment Of Sex Mismatched Bone Marrow Transplantation For Hematological Disorders |
| Technical Method | Fluorescence In Situ Hybridization (FISH) |
| Target Area | Opposite-sex Bone Marrow Transplantation For Hematological Disorders |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.6010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OXP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |