Panels › Clinical Toxicology › Product code LCD · Class 2
Enzyme Immunoassay, Gentamicin
Regulation 862.3450
0510(k)s in 12 months (37 all time)
0recalls in 12 months (13 all time)
11recalls that name a 510(k)
Top companies in LCD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2020 | Abbott Gmbh & Co. KG ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure approp Open, Classified |
LCD | K102699 |
| Aug 13, 2018 | bioMerieux, Inc. VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913
Product Usage:
VITEK 2 is an automated system c Terminated |
LCD | None listed |
| Aug 13, 2018 | bioMerieux, Inc. VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579
Product Usage:
VITEK 2 is an automated system c Terminated |
LCD | None listed |
| Apr 19, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and
17312BB. Terminated |
LCD | K062024 K962819 |
| Apr 19, 2018 | Siemens Healthcare Diagnostics, Inc. Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275. Terminated |
LCD | K062024 K962819 |
| Mar 21, 2011 | Siemens Healthcare Diagnostics, Inc. Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012
This method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human Terminated |
LCD | K062024 |
| Sep 20, 2010 | Beckman Coulter Inc. SYNCHRON Gentamicin (GEN) Reagent
GEN reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 3 Plus, is intended for quantitati Terminated |
LCD | K955644 |
| Mar 8, 2010 | Roche Diagnostics Operations, Inc. Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190.
The product is used for in vitro diagnostic reagent for the quantitative determination of g Terminated |
LCD | K020704 |
| Mar 8, 2010 | Roche Diagnostics Operations, Inc. Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190.
The product is used for in vitro diagnostic reagent for the quantitative determination Terminated |
LCD | K020704 |
| Mar 8, 2010 | Roche Diagnostics Operations, Inc. Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190.
The product is used for in vitro diagnostic reagent for the quantitative dete Terminated |
LCD | K020704 |
| Feb 26, 2008 | Abbott Diagnostic International, Ltd. Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle o Terminated |
LCD | K935376 |
| Sep 1, 2005 | Ortho-Clinical Diagnostics VITROS Chemistry GENT Reagent REF 680 1711, *** Responsible firm on label: Ortho-Clinical Diagnostics Inc., Rochester, NY 14626. Each box contains 6 packs. Each pack contains liquid reagent for 50 Terminated |
LCD | K042479 |
| Jul 20, 2004 | Abbott Laboratories HPD/ADD/GPRD Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
LCD | K840826 K871645 |
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