Panels › Microbiology › Product code MJH · Class 2
Legionella, Spp., Elisa
Regulation 866.3300
0510(k)s in 12 months (10 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in MJH
| Company | 510(k)s | Recalls |
|---|---|---|
| Binax, Inc. | 2 | 0 |
| Inverness Medical Professional Diagnostics | 1 | 1 |
| Meridian Bioscience, Inc. | 2 | 0 |
| Trinity Biotech USA | 1 | 1 |
| Clark Laboratories, Inc. | 0 | 1 |
| Intracel Corp. | 1 | 0 |
| Sa Scientific , Ltd. | 1 | 0 |
| Ssi Diagnostica A/S | 1 | 0 |
| Whittaker Bioproducts, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 5, 2020 | K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test Ssi Diagnostica A/S, DK | MJH |
| Feb 21, 2017 | K163273 | TRU Legionella Meridian Bioscience, Inc. | MJH |
| Feb 24, 2012 | K113190 | TRU LEGIONELLA Meridian Bioscience, Inc. | MJH |
| Jun 28, 2007 | K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST Sa Scientific , Ltd. | MJH |
| Mar 15, 2007 | K070522 | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 Inverness Medical Professional Diagnostics | MJH |
| Nov 26, 2003 | K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM Trinity Biotech USA | MJH |
| Dec 21, 1999 | K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST Intracel Corp. | MJH |
| Aug 21, 1998 | K982238 | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 Binax, Inc. | MJH |
| Sep 20, 1994 | K934965 | BINAX LEGIONELLA URINARY ANTIGEN EIA Binax, Inc. | MJH |
| Jul 30, 1992 | K911356 | LEGIONELLA STAT IGG/IGM TEST KIT Whittaker Bioproducts, Inc. | MJH |
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