Product code MJH
- Device name
- Legionella, Spp., Elisa
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3300
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | Ssi Diagnostica A/S | 2020-03-05 |
| K163273 | TRU Legionella | Meridian Bioscience, Inc. | 2017-02-21 |
| K113190 | TRU LEGIONELLA | Meridian Bioscience, Inc. | 2012-02-24 |
| K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | Sa Scientific , Ltd. | 2007-06-28 |
| K070522 | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 | Inverness Medical Professional Diagnostics | 2007-03-15 |
| K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | Trinity Biotech USA | 2003-11-26 |
| K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST | Intracel Corp. | 1999-12-21 |
| K982238 | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 | Binax, Inc. | 1998-08-21 |
| K934965 | BINAX LEGIONELLA URINARY ANTIGEN EIA | Binax, Inc. | 1994-09-20 |
| K911356 | LEGIONELLA STAT IGG/IGM TEST KIT | Whittaker Bioproducts, Inc. | 1992-07-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840239056450 | Legionella pneumophila IgG ELISA | DRG International Inc | 2023-08-25 |
| 05032384013227 | LEGIONELLA SPECIES TEST KIT | OXOID LIMITED | 2022-12-08 |
| 05713106105573 | ImmuView S. pneumoniae and L. pneumophila urinary antigen test | Ssi Diagnostica A/S | 2022-10-25 |
| 05713106024515 | ImmuView S. pneumoniae and L. pneumophila urinary antigen test | Ssi Diagnostica A/S | 2020-03-24 |
| 05391516746670 | Bartels | CLARK LABORATORIES, INC. | 2019-11-06 |
| 10811877011054 | BinaxNOW™ Legionella Control Swab Pack | Alere Scarborough, Inc. | 2019-07-15 |
| 10811877011023 | BinaxNOW Legionella Urinary Antigen Card | Alere Scarborough, Inc. | 2019-07-08 |
| 04048474056457 | Legionella pneumophila IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 00404847456455 | Legionella pneumophila IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2019-06-10 |
| 05032384061365 | NA | OXOID LIMITED | 2016-09-24 |
| 05032384060542 | NA | OXOID LIMITED | 2016-09-24 |
| 04049016027508 | Anti-Legionella pneumophila ELISA (IgA) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016027515 | Anti-Legionella pneumophila ELISA (IgG) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 04049016027522 | Anti-Legionella pneumophila ELISA (IgM) | EUROIMMUN Medizinische Labordiagnostika AG | 2016-09-24 |
| 05032384013197 | NA | OXOID LIMITED | 2016-09-24 |
| 05032384013203 | NA | OXOID LIMITED | 2016-09-24 |
| 05032384013210 | NA | OXOID LIMITED | 2016-09-24 |
| 05032384060535 | NA | OXOID LIMITED | 2016-09-24 |
| 05391516744065 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-23 |
| 00840733101267 | TRU Legionella | MERIDIAN BIOSCIENCE, INC. | 2016-09-23 |
| 05391516747202 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-19 |
| 10811877010767 | Binax® Legionella EIA Wash Buffer Accessory Kit | Alere Scarborough, Inc. | 2016-09-03 |
| 10811877010460 | Binax® Legionella Urinary Antigen EIA | Alere Scarborough, Inc. | 2016-09-03 |
| 10811877010491 | Alere™ BinaxNOW® Legionella Control Swab Kit | Alere Scarborough, Inc. | 2016-09-01 |
| 10811877010477 | Alere™ BinaxNOW® Legionella Urinary Antigen Card | Alere Scarborough, Inc. | 2016-09-01 |