OWK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Early Growth Response 1 (Egr) Fish Probe Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6040
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA definition
- The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 (K091960) | Abbott Molecular, Inc. | 2011-08-29 | + Add |
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