Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Legionella direct and indirect fluorescent antibody reagents are microbiological diagnostic reagents used to detect Legionella bacteria in patient specimens or environmental samples using fluorescence microscopy techniques, supporting the laboratory diagnosis of Legionnaires' disease. The device is FDA Class 2, indicating moderate risk, regulated under 21 CFR 866.3300 within the Microbiology specialty. It carries product code LHL. No special flags apply to this device.
Basic Information
- Product Code
- LHL
- 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 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K984123 | THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E | Jan 11, 1999 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K970149 | LEGIONELLA ELISA TEST SYSTEM | Jun 18, 1997 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | Mar 03, 1997 | Substantially Equivalent | ARMKEL, LLC. |
| K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | Jul 28, 1992 | Substantially Equivalent | PRO-LAB, INC. |
| K871328 | DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT | Sep 02, 1987 | Substantially Equivalent | E.I. DUPONT DE NEMOURS & CO., INC. |
| K864006 | LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST | Apr 20, 1987 | Substantially Equivalent | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
| K854108 | POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO | Nov 12, 1985 | Substantially Equivalent | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
| K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | Aug 22, 1985 | Substantially Equivalent | GENETIC SYSTEMS CORP. |
| K842683 | GENETIC SYS LEGIONELLA IMMUNOFLURORES | Aug 02, 1984 | Substantially Equivalent | GENETIC SYSTEMS CORP. |
| K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD | Oct 14, 1983 | Substantially Equivalent | BIODAN MEDICAL SYSTEMS, LTD. |
| K831760 | LEGIONELLA IFA KIT I | Aug 08, 1983 | Substantially Equivalent | BIONETIC LABORATORY PRODUCTS |
| K831026 | INDIRECT FLUORESCENT ANTIBODY REAGENTS | Jun 22, 1983 | Substantially Equivalent | ZEUS TECHNOLOGIES |
| K830820 | LEGIONELLA DFA KIT I | Jun 08, 1983 | Substantially Equivalent | BIONETIC LABORATORY PRODUCTS |
| K822859 | DIRECT FA CONJUGATE FOR LEGIONELLA SPP | Feb 16, 1983 | Substantially Equivalent | ZEUS TECHNOLOGIES |
| K822066 | LEGIONELLA PNEUMOPHILA | Sep 21, 1982 | Substantially Equivalent | BIODAN MEDICAL SYSTEMS, LTD. |
| K813339 | DIRECT FA CONJUGATE FOR LEGIONELLA SP | Dec 18, 1981 | Substantially Equivalent | SPRINGWOOD MICROBIOLOGICALS |
| K812007 | LEGIONELLA INDIRECT FLUOR. ANTIBODY | Sep 08, 1981 | Substantially Equivalent | CENTERS FOR DISEASE CONTROL AND PREVENTION |
| K812006 | LEGIONELLA DIRECT FLUORESCENT ANTIBODY | Sep 08, 1981 | Substantially Equivalent | CENTERS FOR DISEASE CONTROL AND PREVENTION |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.