Definition: DNA FISH Probe Kits For Specimen Characterization Detect DNA Probe Targets On Human Chromosomes In Bone Marrow And Peripheral Blood Specimens.
| Device Type ID | 4907 |
| Device Name | Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders |
| Physical State | DNA Probes Labeled With Fluorescent Dyes, Hybridization Buffers, Counterstain |
| Technical Method | Cells From Bone Marrow Or Peripheral Blood Are Obtained From A Patient With A Hematological Disorder. Cells Are Attached To Microscope Slides Using Standard Cytogenetic Procedures. The Resulting Specimen DNA Is Denatured To Single-stranded Form And S |
| Target Area | Bone Marrow And/or Peripheral Blood Specimens |
| Regulation Description | Early Growth Response 1 (EGR1) Gene Fluorescence In-situ Hybridization (FISH) Test System For Specimen Characterization. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 864.1870 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |