Fluorescent Immunoassay Gentamicin
FDA product code LCQ · Class II (moderate risk) · 21 CFR 862.3450 · Clinical Toxicology
19510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Abbott Laboratories 2
- Roche Diagnostic Systems, Inc. 2
- Innotron Diagnostics 1
- Bio-Rad 1
- Oxis Intl., Inc. 1
- Sigma Diagnostics, Inc. 1
- Pb Diagnostic Systems, Inc. 1
- Colony Laboratories, Inc. 1
- Bioprobe Intl., Inc. 1
- Windsor Laboratories, Inc. 1
- Technia Diagnostics , Ltd. 1
- Paragon Diagnostics, Inc. 1
- Syva Co. 1
- American Diagnostic Corp. 1
- Miles Laboratories, Inc. 1
- Hospitax 1
- Intl. Diagnostic Technology 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972609 | Variant Express Glycohemoglobin ProgramLCQ · Traditional | Bio-Rad | 08/06/1997SE |
| K955569 | Innofluor Gentamicin Assay SystemLCQ · Traditional | Oxis Intl., Inc. | 02/09/1996SE |
| K945523 | Cobas(R)-Fp Reagents for Gentamicin and Cobas(R)-Fp Gentamicin CalibratorsLCQ · Traditional | Roche Diagnostic Systems, Inc. | 03/09/1995SE |
| K943550 | Gentamicin Fpia Reagent Set and CalibratorsLCQ · Traditional | Sigma Diagnostics, Inc. | 11/17/1994SE |
| K905721 | Opus GentamicinLCQ · Traditional | Pb Diagnostic Systems, Inc. | 02/21/1991SE |
| K904226 | 'Tdxflx AnalyzerLCQ · Traditional | Abbott Laboratories | 10/29/1990SE |
| K894523 | FPR Gentamicin KitLCQ · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K852158 | Bioprobe Fluor Gentamicin in Serum or PlasmaLCQ · Traditional | Bioprobe Intl., Inc. | 06/25/1985SE |
| K852013 | Gentamicin Kit(Fpia)LCQ · Traditional | Windsor Laboratories, Inc. | 06/10/1985SE |
| K843827 | Cobas Reagents for Gentamicin & CalibratLCQ · Traditional | Roche Diagnostic Systems, Inc. | 02/01/1985SE |
| K841865 | Innoflour GentamicinLCQ · Traditional | Innotron Diagnostics | 05/31/1984SE |
| K841162 | Immpulse Gentamicin Assay ReagentsLCQ · Traditional | Paragon Diagnostics, Inc. | 05/02/1984SE |
| K820285 | Syva Advance Syst. Emit-Amd Gent. AssayLCQ · Traditional | Syva Co. | 02/18/1982SE |
| K813539 | Gentamicin Fluorescent ImmunoassayLCQ · Traditional | American Diagnostic Corp. | 12/31/1981SE |
| K810942 | Ames Tda Gentamicin TestLCQ · Traditional | Miles Laboratories, Inc. | 04/17/1981SE |
| K801867 | Disposable Medication NebulizerLCQ · Traditional | Hospitax | 08/20/1980SE |
| K801084 | Cybrex GentamicinLCQ · Traditional | Abbott Laboratories | 05/23/1980SE |
| K800032 | Fiax Test Kit for Gentamicin Quan.LCQ · Traditional | Intl. Diagnostic Technology | 01/23/1980SE |
| K782025 | Gentamicin Fluroimmunassay KitLCQ · Traditional | Technia Diagnostics , Ltd. | 01/26/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1044-2016 Class II | Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray…The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from… | ConvaTec, Inc | 11/11/2015Terminated |
| Z-0929-2008 | Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use.…Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F… | Abbott Diagnostic International, Ltd. | 10/26/2007Terminated |
| Z-0928-2008 | Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This…Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F… | Abbott Diagnostic International, Ltd. | 10/26/2007Terminated |