LHL · Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Microbiology · 21 CFR 866.3300 · Class 2
Overview
| Product Code | LHL |
|---|---|
| Device Name | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent |
| 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 (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K984123 | THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E | Zeus Scientific, Inc. | Jan 11, 1999 | SESE |
| K970149 | LEGIONELLA ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jun 18, 1997 | SESE |
| K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | Armkel, LLC | Mar 3, 1997 | SESE |
| K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | Pro-Lab, Inc. | Jul 28, 1992 | SESE |
| K871328 | DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT | E.I. Dupont DE Nemours & Co., Inc. | Sep 2, 1987 | SESE |
| K864006 | LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST | Medical Diagnostic Technologies, Inc. | Apr 20, 1987 | SESE |
| K854108 | POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO | Medical Diagnostic Technologies, Inc. | Nov 12, 1985 | SESE |
| K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | Genetic Systems Corp. | Aug 22, 1985 | SESE |
| K842683 | GENETIC SYS LEGIONELLA IMMUNOFLURORES | Genetic Systems Corp. | Aug 2, 1984 | SESE |
| K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD | Biodan Medical Systems, Ltd. | Oct 14, 1983 | SESE |
| K831760 | LEGIONELLA IFA KIT I | Bionetic Laboratory Products | Aug 8, 1983 | SESE |
| K831026 | INDIRECT FLUORESCENT ANTIBODY REAGENTS | Zeus Technologies | Jun 22, 1983 | SESE |
| K830820 | LEGIONELLA DFA KIT I | Bionetic Laboratory Products | Jun 8, 1983 | SESE |
| K822859 | DIRECT FA CONJUGATE FOR LEGIONELLA SPP | Zeus Technologies | Feb 16, 1983 | SESE |
| K822066 | LEGIONELLA PNEUMOPHILA | Biodan Medical Systems, Ltd. | Sep 21, 1982 | SESE |
| K813339 | DIRECT FA CONJUGATE FOR LEGIONELLA SP | Springwood Microbiologicals | Dec 18, 1981 | SESE |
| K812007 | LEGIONELLA INDIRECT FLUOR. ANTIBODY | Centers for Disease Control and Prevention | Sep 8, 1981 | SESE |
| K812006 | LEGIONELLA DIRECT FLUORESCENT ANTIBODY | Centers for Disease Control and Prevention | Sep 8, 1981 | SESE |
Top Applicants
- Biodan Medical Systems, Ltd. — 2 clearances
- Bionetic Laboratory Products — 2 clearances
- Centers for Disease Control and Prevention — 2 clearances
- Genetic Systems Corp. — 2 clearances
- Medical Diagnostic Technologies, Inc. — 2 clearances
