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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2025 | Trinity Biotech USA Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440.
In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease. Open, Classified |
MJH | K991074 |
| Oct 11, 2021 | Clark Laboratories, Inc. Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen Terminated |
MJH | K991074 |
| Nov 29, 2006 | Inverness Medical Professional Diagnostics NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use
Product Code: 852-000 Terminated |
MJH | K982238 |
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