Product code LHL
- Device name
- Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3300
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K984123 | THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E | Zeus Scientific, Inc. | 1999-01-11 |
| K970149 | LEGIONELLA ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1997-06-18 |
| K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | Armkel, LLC | 1997-03-03 |
| K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | Pro-Lab, Inc. | 1992-07-28 |
| K871328 | DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT | E.I. Dupont DE Nemours & Co., Inc. | 1987-09-02 |
| K864006 | LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST | Medical Diagnostic Technologies, Inc. | 1987-04-20 |
| K854108 | POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO | Medical Diagnostic Technologies, Inc. | 1985-11-12 |
| K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | Genetic Systems Corp. | 1985-08-22 |
| K842683 | GENETIC SYS LEGIONELLA IMMUNOFLURORES | Genetic Systems Corp. | 1984-08-02 |
| K832896 | LEGIONELLA INDIRECT FLUORESCENT ANTIBOD | Biodan Medical Systems, Ltd. | 1983-10-14 |
| K831760 | LEGIONELLA IFA KIT I | Bionetic Laboratory Products | 1983-08-08 |
| K831026 | INDIRECT FLUORESCENT ANTIBODY REAGENTS | Zeus Technologies | 1983-06-22 |
| K830820 | LEGIONELLA DFA KIT I | Bionetic Laboratory Products | 1983-06-08 |
| K822859 | DIRECT FA CONJUGATE FOR LEGIONELLA SPP | Zeus Technologies | 1983-02-16 |
| K822066 | LEGIONELLA PNEUMOPHILA | Biodan Medical Systems, Ltd. | 1982-09-21 |
| K813339 | DIRECT FA CONJUGATE FOR LEGIONELLA SP | Springwood Microbiologicals | 1981-12-18 |
| K812006 | LEGIONELLA DIRECT FLUORESCENT ANTIBODY | Centers for Disease Control and Prevention | 1981-09-08 |
| K812007 | LEGIONELLA INDIRECT FLUOR. ANTIBODY | Centers for Disease Control and Prevention | 1981-09-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10628429001834 | Legionella pneumophila Serogroup 1 DFA Kit (50 tests) | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429002046 | Prolex Legionella pneumophila Serogroup 10 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429002039 | Prolex Legionella pneumophila Serogroup 9 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429002022 | Prolex Legionella pneumophila Serogroup 8 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429002015 | Prolex Legionella pneumophila Serogroup 7 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001933 | Legionella pneumophila Positive Control Serogroups 1-14 | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001926 | Legionella pneumophila Serogroup 14 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001919 | Legionella pneumophila Serogroup 13 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001902 | Legionella pneumophila Serogroup 12 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001896 | Legionella pneumophila Serogroup 11 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001889 | Legionella pneumophila Serogroup 10 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001872 | Legionella pneumophila Serogroup 9 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001865 | Legionella pneumophila Serogroup 8 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001858 | Legionella pneumophila Serogroup 7 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001841 | Legionella pneumophila Serogroups 1-14 DFA Kit (50 tests) | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001674 | Legionella pneumophila Serogroup 2 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001827 | Prolex Legionella pneumophila Negative Control Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001810 | Prolex Legionella micdadei | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001803 | Prolex Legionella pneumophila Serogroup 6 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001797 | Prolex Legionella pneumophila Serogroup 5 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001780 | Prolex Legionella pneumophila Serogroup 4 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001773 | Prolex Legionella pneumophila Serogroup 3 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001766 | Prolex Legionella pneumophila Serogroup 2 Latex Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001759 | Legionella DFA Negative Control | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001735 | Phosphate Buffered Saline (pH 7.6) | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001728 | Legionella micdadei DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001711 | Legionella pneumophila Serogroup 6 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001704 | Legionella pneumophila Serogroup 5 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001698 | Legionella pneumophila Serogroup 4 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |
| 10628429001681 | Legionella pneumophila Serogroup 3 DFA Reagent | PRO-LAB, INCORPORATED | 2022-12-25 |