Legionella, Spp., Elisa
The Legionella Spp. ELISA is an enzyme-linked immunosorbent assay used in clinical microbiology laboratories to detect Legionella species antigens or antibodies in patient specimens such as urine or serum, supporting the diagnosis of Legionnaires' disease and related Legionella infections. Classified as a Class 2 device under 21 CFR 866.3300 within the Microbiology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MJH
- Device Class
- FDA class 2
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | Mar 05, 2020 | Substantially Equivalent | Ssi Diagnostica A/S |
| K163273 | TRU Legionella | Feb 21, 2017 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K113190 | TRU LEGIONELLA | Feb 24, 2012 | Substantially Equivalent | Meridian Bioscience, Inc. |
| K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | Jun 28, 2007 | Substantially Equivalent | Sa Scientific , Ltd. |
| K070522 | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 | Mar 15, 2007 | Substantially Equivalent | Inverness Medical Professional Diagnostics |
| K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | Nov 26, 2003 | Substantially Equivalent | Trinity Biotech USA |
| K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST | Dec 21, 1999 | Substantially Equivalent | Intracel Corp. |
| K982238 | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 | Aug 21, 1998 | Substantially Equivalent | Binax, Inc. |
| K934965 | BINAX LEGIONELLA URINARY ANTIGEN EIA | Sep 20, 1994 | Substantially Equivalent | Binax, Inc. |
| K911356 | LEGIONELLA STAT IGG/IGM TEST KIT | Jul 30, 1992 | Substantially Equivalent | Whittaker Bioproducts, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.