Panels › Microbiology › Product code LHL · Class 2
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Regulation 866.3300
0510(k)s in 12 months (18 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in LHL
| Company | 510(k)s | Recalls |
|---|---|---|
| Biodan Medical Systems, Ltd. | 2 | 0 |
| Bionetic Laboratory Products | 2 | 0 |
| Centers for Disease Control and Prevention | 2 | 0 |
| Focus Diagnostics Inc | 0 | 2 |
| Genetic Systems Corp. | 2 | 0 |
| Medical Diagnostic Technologies, Inc. | 2 | 0 |
| Zeus Scientific, Inc. | 2 | 0 |
| Zeus Technologies | 2 | 0 |
| Armkel, LLC | 1 | 0 |
| Diamedix Corporation | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2017 | Focus Diagnostics Inc Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila. Terminated |
LHL | None listed |
| Mar 27, 2017 | Focus Diagnostics Inc Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila. Terminated |
LHL | None listed |
| Feb 15, 2005 | Diamedix Corporation The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert. Terminated |
LHL | K970149 |
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