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Product Classification / EMDN Category

FDA Product Code: LON

Directory of devices assigned to product classification code LON.

classification System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Manufacturer:
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gudid Colibri Daily Verification Kit Manufacturer: COPAN WASP SRL
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gudid Colibr Manufacturer: COPAN WASP SRL
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gudid Colibr Primary Tube for VITEK 2 Manufacturer: COPAN WASP SRL
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gudid Colibri Spreader Manufacturer: COPAN WASP SRL
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gudid MicroScan LabPro V5.03 Data Delivery 07 (US), Electronic Manufacturer: Beckman Coulter, Inc.
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gudid MicroScan LabPro V5.03 System (US), Electronic Manufacturer: Beckman Coulter, Inc.
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gudid MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) Manufacturer: Beckman Coulter, Inc.
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gudid MicroScan LabPro V5.03 Panel Update 11 (US), Electronic Manufacturer: Beckman Coulter, Inc.
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gudid LabPro Data Management System Manufacturer: Beckman Coulter, Inc.
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gudid LabPro-MBT software is a functional subset of LPDMS intended to electronically transfer and display organism identifications from the Bruker MALDI Biotyper System to theLabPro Data Management System. LabPro-MBT software is a device that is intended to electronically transfer medical device data, without controlling or altering the functions or parameters of any connected medical devices. Manufacturer: Beckman Coulter, Inc.
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gudid LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agentsusceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results, for use by trained laboratory personnel.LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes Beckman Coulter ID and AST data, or other pre-defined parameters, against a series of established rules/ alerts and notifies the user of unusual, and/or critical conditions, which may warrant further analysis or action. Manufacturer: Beckman Coulter, Inc.
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gudid LabPro Data Management System Manufacturer: Beckman Coulter, Inc.
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gudid Selux Seaparator Reagent Kit Manufacturer: Selux Diagnostics, Inc.
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gudid Selux AST Gram Positive Panels Manufacturer: Selux Diagnostics, Inc.
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gudid PBC Separator with Selux AST System Manufacturer: Selux Diagnostics, Inc.
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gudid AST Analyzer Manufacturer: Selux Diagnostics, Inc.
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gudid AST Inoculator Manufacturer: Selux Diagnostics, Inc.
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gudid Selux AST Gram Negative Panel Manufacturer: Selux Diagnostics, Inc.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid Knowledge Base Update for VITEK2 Software Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK2 software 9.01 update, advanced software to run your VITEK2 system, second version Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid Vitek 2 software V10 Manufacturer: BIOMERIEUX , INC.
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gudid Saline Solution is a diluent used for manual preparation of organism suspensions, prior to identification and antimicrobial susceptibility processing with VITEK 2 instruments. Manufacturer: BIOMERIEUX SA
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK COMPACT PRO is an automated system that performs bacterial ID and AST. minimum, a total of 15 ID and/or AST cards can be processed simultaneously per run. can be extended to 30 or 60. Manufacturer: BIOMERIEUX , INC.
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gudid Knowledge Base Update for VITEK 2 Software 09.03 Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid CD with VITEK 2 09.02 software version Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid The POD is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacterial suspension. It is used for the Vitek instrument to prepare ID and AST test. Manufacturer: BIOMERIEUX , INC.
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gudid VITEK DENSICHEK CONNECTIVITY BASE Kit that include one pod and one connecrtivity base Manufacturer: BIOMERIEUX , INC.
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gudid The DISPLAY is part of the VITEK DensiCHEK that allows to read the McFarland value for a bacterial suspension. It is used for the Vitek instrument to prepare ID and AST test. Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clinically significant aerobic gramnegative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2.0 0.45% SALINE INDIVIDUAL BAG Manufacturer: BIOMERIEUX , INC.
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gudid VITEK2 software 9.01.0, advanced software to run your VITEK2 system Manufacturer: BIOMERIEUX , INC.
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gudid The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 software 8.01 update, advanced software to run your VITEK 2 system Manufacturer: BIOMERIEUX , INC.
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gudid These are calibration standards for the DensiCHEK Plus instrument which is designed for use with the VITEK2 to measure the optical density of a bacterial suspension. Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of clinically significant aerobic gram-negative bacilli Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine susceptibility of Staphylococcus spp., Enterococcus spp., & S. agalactiae Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine susceptibility of Staphylococcus spp., Enterococcus spp., & S. agalactiae Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine susceptibility of Staphylococcus spp., Enterococcus spp., & S. agalactiae Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae Manufacturer: BIOMERIEUX , INC.
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gudid The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of S. pneumo , beta-hemolytic Strep, & Viridans Strep Manufacturer: BIOMERIEUX , INC.
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gudid The DENSICHEK Plus instrument is designed for use with the VITEK2 System to measure the optical density of a microorganism suspension. Manufacturer: BIOMERIEUX , INC.
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gudid These are calibration standards for the DensiCHEK Plus instrument. This instrument is uses with the VITEK2 to measure the optical density of bacterial suspensions. Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 COMPACT 15 is an automated system that performs bacterial ID and AST. A total of 15 ID and/or AST cards can be processed simultaneously per run. Manufacturer: BIOMERIEUX , INC.
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gudid VITEK 2 COMPACT 15 is an automated system that performs bacterial ID and AST. A total of 15 ID and/or AST cards can be processed simultaneously per run. Manufacturer: BIOMERIEUX , INC.
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