Home › Device types › MJH
Legionella, Spp., Elisa
FDA product code MJH · Class 2 · Microbiology
24
Registered devices
5
Adverse events
3
Recalls
10
510(k) clearances
Devices with this code
Anti-Legionella pneumophila ELISA (IgM) — EUROIMMUN Medizinische Labordiagnostika AGNA — OXOID LIMITEDBartels — CLARK LABORATORIES, INC.NA — OXOID LIMITEDAlere™ BinaxNOW® Legionella Control Swab Kit — Alere Scarborough, Inc.BinaxNOW Legionella Urinary Antigen Card — Alere Scarborough, Inc.Binax® Legionella EIA Wash Buffer Accessory Kit — Alere Scarborough, Inc.Anti-Legionella pneumophila ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGNA — OXOID LIMITEDAlere™ BinaxNOW® Legionella Urinary Antigen Card — Alere Scarborough, Inc.NA — OXOID LIMITEDNA — OXOID LIMITEDImmuView S. pneumoniae and L. pneumophila urinary antigen test — Ssi Diagnostica A/SNA — OXOID LIMITEDLegionella pneumophila IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungBinax® Legionella Urinary Antigen EIA — Alere Scarborough, Inc.BinaxNOW™ Legionella Control Swab Pack — Alere Scarborough, Inc.LEGIONELLA SPECIES TEST KIT — OXOID LIMITEDLegionella pneumophila IgG ELISA — DRG International IncTrinity Biotech — CLARK LABORATORIES, INC.Anti-Legionella pneumophila ELISA (IgA) — EUROIMMUN Medizinische Labordiagnostika AGTRU Legionella — MERIDIAN BIOSCIENCE, INC.Trinity Biotech — CLARK LABORATORIES, INC.ImmuView S. pneumoniae and L. pneumophila urinary antigen test — Ssi Diagnostica A/S
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-22 | Trinity Biotech USA | Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter. |
| 2021-10-11 | Clark Laboratories, Inc. | Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay |
| 2006-09-29 | Inverness Medical Professional Diagnostics | Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches |
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