LJD
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, B Lymphocyte Marker
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ANTI-LEU-12 B CELL REAGENT (K851639) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-07-02 | + Add |
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