FDA Product Code LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Under FDA product code LON, automated antimicrobial susceptibility testing systems are cleared for use in clinical microbiology laboratories.
Unlike manual methods, LON systems automatically inoculate, incubate, and read antimicrobial susceptibility panels, delivering results in hours rather than days. They are essential in high-volume laboratories requiring rapid, standardized antibiotic susceptibility data.
LON devices are Class II medical devices, regulated under 21 CFR 866.1645 and reviewed by the FDA Microbiology panel.
Leading manufacturers include bioMerieux, Inc., Becton, Dickinson & CO and Dade Behring, Inc..
289
Total
289
Cleared
90d
Avg days
1986
Since
289 devices
Cleared
Feb 17, 2005
VITEK 2 COMPACT
bioMerieux, Inc.
Microbiology
45d
Cleared
Jan 21, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML
Becton, Dickinson & CO
Microbiology
43d
Cleared
Dec 30, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
bioMerieux, Inc.
Microbiology
38d
Cleared
Dec 23, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
bioMerieux, Inc.
Microbiology
31d
Cleared
Dec 13, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
bioMerieux, Inc.
Microbiology
47d
Cleared
Dec 07, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
bioMerieux, Inc.
Microbiology
42d
Cleared
Dec 02, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML
Becton, Dickinson & CO
Microbiology
41d
Cleared
Sep 14, 2004
VITEK 2 GRAM NEGATIVE ERTAPENEM
bioMerieux, Inc.
Microbiology
53d
Cleared
Aug 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE
Becton, Dickinson & CO
Microbiology
70d
Cleared
Jun 08, 2004
VITEK 2 ESBL TEST
bioMerieux, Inc.
Microbiology
68d
Cleared
May 28, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
Becton, Dickinson & CO
Microbiology
211d
Cleared
May 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
Becton, Dickinson & CO
Microbiology
56d
Cleared
Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE
Becton, Dickinson & CO
Microbiology
171d
Cleared
Apr 09, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML
Becton, Dickinson & CO
Microbiology
114d
Cleared
Apr 02, 2004
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
Dade Behring, Inc.
Microbiology
317d
Cleared
Mar 19, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
Becton, Dickinson & CO
Microbiology
59d
Cleared
Mar 11, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE
Becton, Dickinson & CO
Microbiology
51d
Cleared
Mar 01, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
Becton, Dickinson & CO
Microbiology
185d
Cleared
Feb 27, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE
Becton, Dickinson & CO
Microbiology
56d
Cleared
Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML
Becton, Dickinson & CO
Microbiology
61d
Cleared
Feb 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE
Becton, Dickinson & CO
Microbiology
49d
Cleared
Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE
Becton, Dickinson & CO
Microbiology
63d
Cleared
Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
Becton, Dickinson & CO
Microbiology
63d
Cleared
Dec 19, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
Becton, Dickinson & CO
Microbiology
37d