MJH · Legionella, Spp., Elisa
Microbiology · 21 CFR 866.3300 · Class 2
Overview
| Product Code | MJH |
|---|---|
| Device Name | Legionella, Spp., Elisa |
| Regulation | 21 CFR 866.3300 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identify Haemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Haemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused by Haemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191184 | ImmuView S pneumoniae and L pneumophila Urinary Antigen Test | Ssi Diagnostica A/S | Mar 5, 2020 | SESE |
| K163273 | TRU Legionella | Meridian Bioscience, Inc. | Feb 21, 2017 | SESE |
| K113190 | TRU LEGIONELLA | Meridian Bioscience, Inc. | Feb 24, 2012 | SESE |
| K061496 | SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST | Sa Scientific , Ltd. | Jun 28, 2007 | SESE |
| K070522 | MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 | Inverness Medical Professional Diagnostics | Mar 15, 2007 | SESE |
| K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | Trinity Biotech USA | Nov 26, 2003 | SESE |
| K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST | Intracel Corp. | Dec 21, 1999 | SESE |
| K982238 | BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 | Binax, Inc. | Aug 21, 1998 | SESE |
| K934965 | BINAX LEGIONELLA URINARY ANTIGEN EIA | Binax, Inc. | Sep 20, 1994 | SESE |
| K911356 | LEGIONELLA STAT IGG/IGM TEST KIT | Whittaker Bioproducts, Inc. | Jul 30, 1992 | SESE |
Top Applicants
- Meridian Bioscience, Inc. — 2 clearances
- Binax, Inc. — 2 clearances
- Whittaker Bioproducts, Inc. — 1 clearance
- Trinity Biotech USA — 1 clearance
- Ssi Diagnostica A/S — 1 clearance
