DGX
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ng1m(A), Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5065
- Medical specialty
- Immunology
- Adverse events (MAUDE)
- 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ALLO-TYPE HUMAN IMMUNOGLOBULIN- (K841114) | Genetic Testing Institute | 1984-06-14 |
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Every clearance here is in the API, with alerts when new ones post.