PFG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1870
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- FDA definition
- DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.
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| Record | Firm | Date |
|---|---|---|
| VYSIS D7S486/CEP 7 FISH PROBE KIT (K131508) | Abbott Molecular, Inc. | 2013-09-13 |
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