GRP
6 FDA 510(k) clearances · Product code
49 daysmedian time to decision
140 days90th percentile
6clearances measured
FDA profile
- Official device name
- Antisera, All Types, H. Influenza
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3300
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2005: 2 · 2006: 2
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 |
|---|---|---|
| BACTIGEN(R) H. INFLUENZAE TYPE B (K884967) | Armkel, LLC | 1989-02-07 |
| IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES (K854490) | American Micro Scan | 1985-12-27 |
| H-FLU B ELISA TEST (K831525) | Seragen Diagnostics, Inc. | 1983-09-29 |
| H. INFLUENZA B ANTISERA FOR CIE (K823348) | Diagnostica, Inc. | 1982-12-28 |
| BBL DIRECTIGEN MENINGITIS TEST KIT (K821266) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-01 |
| HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (K820192) | Hyland Therapeutic Div., Travenol Laboratories | 1982-03-11 |
Track GRP automatically
Every clearance here is in the API, with alerts when new ones post.