MJH
10 FDA 510(k) clearances · Product code
265 daysmedian time to decision
490 days90th percentile
10clearances measured
FDA profile
- Official device name
- Legionella, Spp., Elisa
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3300
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (K191184) | Ssi Diagnostica A/S | 2020-03-05 |
| TRU Legionella (K163273) | Meridian Bioscience, Inc. | 2017-02-21 |
| TRU LEGIONELLA (K113190) | Meridian Bioscience, Inc. | 2012-02-24 |
| SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (K061496) | Sa Scientific , Ltd. | 2007-06-28 |
| MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 (K070522) | Inverness Medical Professional Diagnostics | 2007-03-15 |
| LEGIONELLA PNEUMOPHILA IGG/IGM (K033051) | Trinity Biotech USA | 2003-11-26 |
| BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST (K991074) | Intracel Corp. | 1999-12-21 |
| BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 (K982238) | Binax, Inc. | 1998-08-21 |
| BINAX LEGIONELLA URINARY ANTIGEN EIA (K934965) | Binax, Inc. | 1994-09-20 |
| LEGIONELLA STAT IGG/IGM TEST KIT (K911356) | Whittaker Bioproducts, Inc. | 1992-07-30 |
Track MJH automatically
Every clearance here is in the API, with alerts when new ones post.