FDA product code MJH: Legionella, Spp., Elisa
MJH is the FDA product code for legionella, spp., elisa. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel. FDA has cleared 10 510(k) submissions under MJH, from 8 different applicants. The average 510(k) review took 214 days (median 190). FDA has posted 3 recalls for MJH devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Legionella, Spp., Elisa |
| Device class | Class II |
| Regulation | 21 CFR 866.3300 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for MJH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 92 |
| 2020 | 1 | 307 |
Compare with all 510(k) review times · Search every MJH clearance
Top MJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Bioscience, Inc. | 2 | 2017-02-21 |
| Binax, Inc. | 2 | 1998-08-21 |
| Ssi Diagnostica A/S | 1 | 2020-03-05 |
| Sa Scientific , Ltd. | 1 | 2007-06-28 |
| Inverness Medical Professional Diagnostics | 1 | 2007-03-15 |
3 more applicants have MJH clearances. See the full list in Caduvo.
Most recent MJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191184 | Ssi Diagnostica A/S | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | 2020-03-05 | 307 |
| K163273 | Meridian Bioscience, Inc. | TRU Legionella | 2017-02-21 | 92 |
| K113190 | Meridian Bioscience, Inc. | TRU LEGIONELLA | 2012-02-24 | 116 |
| K061496 | Sa Scientific , Ltd. | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | 2007-06-28 | 393 |
| K070522 | Inverness Medical Professional Diagnostics | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 | 2007-03-15 | 20 |
Recalls for MJH devices
3 product recalls in 3 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2025-07-22.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MJH?
MJH is the FDA product code for legionella, spp., elisa. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel.
What device class is MJH?
Class II, regulation 21 CFR 866.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MJH?
Across 10 cleared submissions the average was 214 days from receipt to decision (median 190).
Which companies have the most MJH clearances?
Meridian Bioscience, Inc. (2); Binax, Inc. (2); Ssi Diagnostica A/S (1); Sa Scientific , Ltd. (1); Inverness Medical Professional Diagnostics (1).
Have MJH devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-07-22.
Next steps
- Run an FDA pathway report with predicate devices for product code MJH
- Run a recall and safety report across every MJH manufacturer
- Watch product code MJH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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