Infectious diseasesBacteriology (infect. immunology/NAT)Legionella
Legionella antigen detection
EMDN code W0105010501
Manufacturers registered in Europe (EUDAMED) 14
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 19
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| PRO-LAB, INCORPORATED Present in Europe in other categories | Canada | Legionella pneumophila Serogroup 13 DFA Reagent Prolex Legionella pneumophila Serogroup 7 Latex Reagent Prolex Legionella pneumophila Serogroup 4 Latex Reagent Legionella pneumophila Serogroup 5 DFA Reagent Prolex Legionella pneumophila Serogroup 3 Latex Reagent Prolex Legionella pneumophila Serogroup 1 Latex Reagent (Monoclonal) | K921421 (1992) |
| MARDX DIAGNOSTICS, INC. | United States | Trinity Biotech | registered |
| SCIMEDX CORPORATION | – | L. pneu 1-6C/Specimen Slide L.pneu 1-6 IFA Poly(HT)60 Test L. pneu 1-6/bdglmj DFA Screen L.pneu Gr.1(Mono)(HT) 18 Well L.pneu 1-6/bdglmj/C Specimen Slide L.pneuGR1-6&Mic.Screen(HT)18W | registered |
| MICROGEN BIOPRODUCTS LIMITED | – | M45b Test Reagent 2-15 M45c Positive Control Microgen Legionella M45a Test Reagent 1 M45d Test Reagent Species | registered |
| Alere Scarborough, Inc. | United States | Binax® Legionella Urinary Antigen EIA BinaxNOW Legionella Urinary Antigen Card BinaxNOW™ Legionella Control Swab Pack Binax® Legionella EIA Wash Buffer Accessory Kit | registered |
| CLARK LABORATORIES, INC. | United States | Trinity Biotech Bartels | registered |
| Ssi Diagnostica A/S Present in Europe in other categories | Denmark | ImmuView S. pneumoniae and L. pneumophila urinary antigen test | K191184 (2020) |
| Bio-Rad Present in Europe in other categories | United States | Kallestad | registered |
| DRG Instruments Gesellschaft mit beschränkter Haftung | – | Legionella pneumophila IgG ELISA | registered |
| DRG International Inc | United States | Legionella pneumophila IgG ELISA | registered |
| EUROIMMUN Medizinische Labordiagnostika AG Present in Europe in other categories | Germany | Anti-Legionella pneumophila ELISA (IgG) | registered |
| MAST GROUP LIMITED Present in Europe in other categories | United Kingdom | Mast Assure Antisera | registered |
| Meridian Bioscience, Inc. Present in Europe in other categories | United States | TRU Legionella | K163273 (2017) |
| ACESO LABORATORIES INC. Present in Europe in other categories | United States | – | registered |
| BIOCHECK, INC. | United States | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Sa Scientific, Inc. | United States | – | K061496 (2007) |
| Trinity Biotech USA Present in Europe in other categories | United States | – | K033051 (2003) |
| Zeus Scientific, Inc. Present in Europe in other categories | United States | – | K984123 (1999) |
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