LJY
8 FDA 510(k) clearances · Product code
168 daysmedian time to decision
737 days90th percentile
8clearances measured
FDA profile
- Official device name
- Enzyme Linked Immunoabsorbent Assay, Mumps Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3380
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1996: 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 |
|---|---|---|
| MUMPS IGG ELISA TEST SYSTEM (K991274) | Columbia Bioscience, Inc. | 1999-09-03 |
| SERAQUEST MUMPS IGG (K980059) | Quest Intl., Inc. | 1998-04-23 |
| MUMPS IGG ELISA TESTY (K971857) | Gull Laboratories, Inc. | 1997-11-04 |
| MUMPS IGG TEST (K961204) | Zeus Scientific, Inc. | 1996-07-18 |
| MUMPS STAT (K925209) | Biowhittaker Molecular Applications, Inc. | 1994-10-14 |
| VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA (K923903) | Biomerieux Vitek, Inc. | 1993-08-09 |
| PHARMACIA MUMPS IGG ELISA (K897006) | Pharmacia Eni Diagnostics, Inc. | 1990-07-26 |
| MUMPSELISA TEST KIT (K830045) | M.A. Bioproducts | 1983-05-13 |
Track LJY automatically
Every clearance here is in the API, with alerts when new ones post.