FDA 510(k) Applications for Medical Device Product Code "LON"
(System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)

FDA 510(k) Number Applicant Device Name Decision Date
K032153 BD DIAGNOSTIC SYSTEMS BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML 09/11/2003
K030091 BD DIAGNOSTIC SYSTEMS BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML 02/28/2003
K031429 BD DIAGNOSTIC SYSTEMS BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML 06/06/2003
K201405 Beckman Coulter Inc. LabPro Data Management System 08/30/2020
K063573 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML 01/11/2007
K023301 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM 11/12/2002
K033560 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS 01/14/2004
K033784 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML 02/03/2004
K060217 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML 04/12/2006
K060447 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) 04/26/2006
K060324 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE 05/25/2006
K033362 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE 04/09/2004
K040006 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE 02/27/2004
K031530 BECTON DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML 07/10/2003
K050780 BECTON DICKINSON & CO. BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML 05/12/2005
K032131 BECTON, DICKINSON & CO. BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS 08/18/2003
K050881 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML 05/12/2005
K031912 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML 07/21/2003
K020321 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM 05/23/2002
K020322 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM 03/27/2002
K020323 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM 04/04/2002
K022172 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM 08/12/2002
K023568 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM 01/24/2003
K023858 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM 12/20/2002
K040099 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM 03/19/2004
K051692 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML 07/14/2005
K061355 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML 06/07/2006
K050089 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML 02/28/2005
K063824 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML 02/14/2007
K033558 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS 12/19/2003
K063811 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML 02/09/2007
K050555 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML 04/14/2005
K060444 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML 04/12/2006
K063301 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML 12/08/2006
K043458 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML 03/15/2005
K060257 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML 04/14/2006
K053241 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML 12/22/2005
K063300 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML 01/29/2007
K041384 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE 08/03/2004
K062944 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML 11/15/2006
K051138 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML 06/03/2005
K062207 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML 09/13/2006
K052270 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML 10/05/2005
K031943 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML 08/06/2003
K050400 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML 03/22/2005
K023895 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN 01/08/2003
K051272 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML 07/11/2005
K033458 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST 05/28/2004
K051689 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML 08/05/2005
K062945 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML 11/21/2006
K051109 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML 06/15/2005
K060218 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML 03/17/2006
K051183 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML 06/21/2005
K023273 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML 10/31/2002
K051266 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML 07/05/2005
K062206 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML 09/08/2006
K031306 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE 06/02/2003
K023527 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML 12/23/2002
K024152 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML 01/31/2003
K024153 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML 02/10/2003
K062680 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML 10/05/2006
K033557 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE 01/14/2004
K052250 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML 09/30/2005
K033907 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML 04/09/2004
K031699 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML 07/30/2003
K131331 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) 07/10/2013
K060493 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA. 03/29/2006
K040106 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE 03/11/2004
K043389 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML 01/21/2005
K052269 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN 10/03/2005
K051204 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML 06/24/2005
K060558 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML 05/11/2006
K033889 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE 02/03/2004
K063486 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY 03/07/2007
K022129 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML 07/25/2002
K030986 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML 05/16/2003
K123404 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) 06/27/2013
K023444 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML 11/12/2002
K061327 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0. 07/03/2006
K061673 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML 07/28/2006
K061867 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML 08/10/2006
K032675 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML 03/01/2004
K032567 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE 09/17/2003
K032655 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML 10/06/2003
K021954 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML 08/01/2002
K073589 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS 03/05/2008
K082913 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML 12/05/2008
K023634 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) 12/24/2002
K032275 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS 09/29/2003
K050946 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML 05/27/2005
K070809 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML 09/24/2007
K030579 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML 03/21/2003
K082852 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML 01/29/2009
K031589 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE 07/11/2003
K040716 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML 05/14/2004
K082538 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST 11/20/2008
K073433 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML 01/14/2008
K061869 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML 08/18/2006
K042932 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML 12/02/2004
K031984 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML 08/27/2003
K050865 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML 05/20/2005
K030677 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE 04/01/2003
K071623 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML 08/20/2007
K050747 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML 04/29/2005
K050745 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML 04/29/2005
K032299 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML 09/22/2003
K062687 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML 10/24/2006
K060214 BECTON, DICKINSON & CO. BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML 03/09/2006
K031679 BECTON, DICKINSON & CO. BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM 07/16/2003
K050982 BECTON, DICKINSON & CO. BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) 05/24/2005
K163637 BECTON, DICKINSON & COMPANY BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) 03/21/2017
K041572 BECTON, DICKINSON AND CO. BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML 08/12/2004
K140468 Becton, Dickinson and Company BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) 06/02/2014
K173523 Becton, Dickinson and Company BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) 02/09/2018
K132909 Becton, Dickinson and Company BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML) 02/14/2014
K190905 Becton, Dickinson and Company BD Phoenix Automated Microbiology System û GN Ceftaroline (0.0156-4 ╡g/mL) 07/01/2019
K132674 Becton, Dickinson and Company BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) 12/27/2013
K151320 BECTON, DICKINSON AND COMPANY BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml 01/15/2016
K142170 Becton, Dickinson and Company BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP 10/28/2014
K123266 Becton, Dickinson and Company BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN 06/26/2013
K173252 Becton, Dickinson, and Company BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) 01/05/2018
K181665 Becton,Dickinson and Company BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN 09/21/2018
K222430 bioMerieux SA, Inc. VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 ╡g/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 ╡g/mL), VITEK 2 AST-GN Fosfomycin 03/09/2023
K212243 bioMerieux, Inc VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 ╡g/mL) 08/08/2022
K210287 bioMerieux, Inc VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) 10/28/2021
K161227 BIOMERIEUX, INC VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) 07/20/2016
K162737 bioMerieux, Inc VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4╡g/mL) 06/21/2017
K163563 bioMerieux, Inc VITEK 2 AST-GN Gentamicin (<=1 û >=16 ╡g/mL) 03/13/2017
K222073 bioMerieux, Inc VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) 02/09/2023
K214023 bioMerieux, Inc VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 ╡g/mL) 04/14/2022
K152075 bioMerieux, Inc VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) 04/15/2016
K211136 BioMerieux, Inc VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) 06/14/2021
K183360 bioMerieux, Inc VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 û >=64/8 ╡g/mL) 02/26/2019
K211630 bioMerieux, Inc VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 ╡g/mL) 08/30/2021
K220805 bioMerieux, Inc VITEK 2 AST-Gram Positive Cefoxitin Screen 10/13/2022
K230864 BioMerieux, Inc VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 ╡g/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 ╡g/mL), VITEK 2 AST-GP Daptomycin 07/05/2023
K200590 bioMerieux, Inc VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 ╡g/mL) 04/28/2020
K181766 bioMerieux, Inc VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance 12/10/2018
K220803 bioMerieux, Inc VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 ╡g/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 ╡g/mL), VITEK 2 AST-GP Moxifloxacin 01/27/2023
K192110 bioMerieux, Inc Vitek Densichek 10/31/2019
K223478 bioMerieux, Inc VITEK« 2 AST-Gram Negative Plazomicin (=0.5 - =16 ╡g/mL); VITEK« 2 AST-GN Plazomicin (=0.5 - =16 ╡g/mL); VITEK« 2 AST-GN Plazomicin 02/16/2023
K223481 bioMerieux, Inc VITEK« 2 Streptococcus Tetracycline (<=0.25 - >=16 ╡g/mL) 02/03/2023
K161510 BIOMERIEUX, INC VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) 02/13/2017
K093224 BIOMERIEUX, INC. DENSICHECK PLUS 11/09/2009
K083536 BIOMERIEUX, INC. DENSICHEK PLUS 09/11/2009
K122547 BIOMERIEUX, INC. GRAM POSTITVE CLINDAMYCIN 10/15/2012
K020870 BIOMERIEUX, INC. VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN 03/25/2002
K020871 BIOMERIEUX, INC. VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN 03/29/2002
K141149 BIOMERIEUX, INC. VITEK 2 AST GP CEFTAROLINE 06/20/2014
K161437 BIOMERIEUX, INC. VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) 02/16/2017
K132507 BIOMERIEUX, INC. VITEK 2 AST ST MEROPENEM 11/15/2013
K132573 BIOMERIEUX, INC. VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN 09/13/2013
K121100 BIOMERIEUX, INC. VITEK 2 AST STREPTOCOCUS VANCOMYCIN 11/19/2012
K193567 BioMerieux, Inc. VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 û >=16 ug/mL) 02/14/2020
K113783 BIOMERIEUX, INC. VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE 08/07/2012
K172731 bioMerieux, Inc. VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) 12/08/2017
K172944 bioMerieux, Inc. VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 û >=16 ╡g/mL 12/19/2017
K113200 BIOMERIEUX, INC. VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM 06/29/2012
K163006 bioMerieux, Inc. VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) 01/24/2017
K163083 bioMerieux, Inc. VITEK 2 AST-GN Tobramycin (/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (/=16 ug/mL) 02/01/2017
K193299 BioMerieux, Inc. VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 ╡g/mL) 09/28/2020
K191766 bioMerieux, Inc. VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4╡g/mL) 08/05/2019
K183415 bioMerieux, Inc. VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL) 02/20/2019
K193572 BioMerieux, Inc. VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 ╡g/mL) 03/13/2020
K222378 bioMerieux, Inc. VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL) 06/26/2023
K201675 bioMerieux, Inc. VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 ╡g/mL) 07/09/2021
K183551 bioMerieux, Inc. VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) 03/07/2019
K213931 bioMerieux, Inc. VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 ╡g/mL) 06/03/2022
K190616 bioMerieux, Inc. VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 ╡g/mL) 06/06/2019
K202396 bioMerieux, Inc. VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) 09/14/2021
K121863 BIOMERIEUX, INC. VITEK 2 AST-ST CEFOTAXIME 08/16/2012
K111599 BIOMERIEUX, INC. VITEK 2 AST-ST LINEZOLID 08/12/2011
K131779 BIOMERIEUX, INC. VITEK 2 AST-ST TIGECYCLINE 10/10/2013
K213899 bioMerieux, Inc. VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 ╡g/mL), VITEK 2 AST-YS Caspofungin 07/12/2022
K213241 BioMerieux, Inc. VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 ╡g/mL), VITEK 2 AST-YS Fluconazole 02/25/2022
K050002 BIOMERIEUX, INC. VITEK 2 COMPACT 02/17/2005
K040845 BIOMERIEUX, INC. VITEK 2 ESBL TEST 06/08/2004
K161217 bioMerieux, Inc. VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) 01/12/2017
K082346 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE DORIPENEM 03/16/2009
K121546 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE DOXYCYCLINE 11/20/2012
K041982 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE ERTAPENEM 09/14/2004
K032788 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE GATIFLOXACIN 11/04/2003
K072038 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE LEVOFLOXACIN 09/12/2007
K091899 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE MEROPENEM 08/14/2009
K032861 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE MOXIFLOXACIN 11/12/2003
K073083 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE PIPERACILLIN 12/10/2007
K080107 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM 02/28/2008
K052311 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE TIGECYCLINE 09/29/2005
K110106 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE 11/30/2011
K073406 BIOMERIEUX, INC. VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE 01/23/2008
K063597 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE 01/19/2007
K053097 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN 12/14/2005
K050075 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE DAPTOMYCIN 02/28/2005
K091126 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE DAPTOMYCIN 06/18/2009
K093076 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE DOXCYCLINE 10/21/2010
K050076 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE ERTAPENEM 02/18/2005
K051849 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE 08/16/2005
K063492 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE 12/21/2006
K083383 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE 02/18/2009
K032314 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE GATIFLOXACIN 08/22/2003
K080201 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE 04/30/2008
K032766 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE LINEZOLID 10/31/2003
K031410 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE 07/10/2003
K050816 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE MEROPENEM 05/12/2005
K063623 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE 01/11/2007
K032399 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE MOXIFLOXACIN 09/10/2003
K031865 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE 08/13/2003
K032738 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN 10/31/2003
K053186 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE 12/01/2005
K072695 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE TIGECYCLINE 11/16/2007
K050976 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE 05/23/2005
K072668 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE VANCOMYCIN 10/15/2007
K061347 BIOMERIEUX, INC. VITEK 2 GRAM POSITIVE VRSA SCREEN 06/20/2006
K111976 BIOMERIEUX, INC. VITEK 2 STREPTOCOCCUS ERYTHROMYCIN 02/17/2012
K111909 BIOMERIEUX, INC. VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE 10/18/2011
K112228 BIOMERIEUX, INC. VITEK 2 STREPTOCOCCUS LEVOFLOXACIN 10/03/2011
K112000 BIOMERIEUX, INC. VITEK 2 STREPTOCOCCUS PENICILLIN 10/26/2011
K113305 BIOMERIEUX, INC. VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE 02/10/2012
K112075 BIOMERIEUX, INC. VITEK 2 STRPTOCOCCUS AMPICILLIN 09/15/2011
K122359 BIOMERIEUX, INC. VITEK 2 STRPTOCOCCUS CEFTRIAXONE 08/28/2012
K103752 BIOMERIEUX, INC. VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE 10/14/2011
K032711 BIOMERIEUX, INC. VITEK GRAM NEGATIVE GATIFLOXACIN 10/31/2003
K043230 BIOMERIEUX, INC. VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM 12/30/2004
K043237 BIOMERIEUX, INC. VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN 12/23/2004
K042963 BIOMERIEUX, INC. VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM 12/13/2004
K022045 BIOMERIEUX, INC. VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID 08/15/2002
K042946 BIOMERIEUX, INC. VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN 12/07/2004
K052656 BIOMERIEUX, INC. VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN 11/07/2005
K112129 BIOMERIEUX, INC. VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN 09/27/2011
K111893 BIOMERIEUX, INC. VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE 02/28/2012
K183524 bioMerieux, Inc. VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) 03/12/2019
K212849 bioMΘrieux, Inc VITEK 2 AST-Gram Positive Linezolid (<=0.5 û >=8 ╡g/mL) 02/04/2022
K220546 Copan WASP S.r.l. Colibrφ System 10/05/2022
K070346 DADE BEHRING, INC. DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM 07/18/2007
K020249 DADE BEHRING, INC. MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) 02/06/2002
K020185 DADE BEHRING, INC. MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML) 02/06/2002
K020410 DADE BEHRING, INC. MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML) 06/11/2002
K020142 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS 03/14/2002
K020413 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) 07/17/2002
K020209 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) 02/06/2002
K020398 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) 05/16/2002
K033482 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) 11/26/2003
K020319 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML) 04/17/2002
K020328 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML) 02/19/2002
K031601 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML) 04/02/2004
K023361 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML) 12/16/2002
K020246 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) 02/06/2002
K023541 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) 12/13/2002
K020182 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) 02/06/2002
K031602 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) 07/31/2003
K020397 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML) 04/22/2002
K020173 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) 02/06/2002
K020248 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML) 03/14/2002
K060088 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN 02/03/2006
K051478 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN 07/27/2005
K071317 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN 08/20/2007
K071268 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE 06/26/2007
K051311 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN 07/12/2005
K063366 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE 12/08/2006
K063564 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) 02/08/2007
K070860 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN 05/11/2007
K053504 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) 02/24/2006
K062938 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML 11/20/2006
K060312 DADE BEHRING, INC. MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML) 03/23/2006
K020168 DADE BEHRING, INC. MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) 02/06/2002
K051350 DADE BEHRING, INC. SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS 07/25/2005
K052346 DADE BEHRING, INC. SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS 10/26/2005
K071076 DADE BEHRING, INC. SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS 05/21/2007
K063365 DADE BEHRING, INC. SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE 12/08/2006
K062705 DADE BEHRING, INC. SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID 10/20/2006
K020511 DADE MICROSCAN, INC. MICROSCAN SYNERGIES PLUS 03/06/2002
K020506 DADE MICROSCAN, INC. MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) 04/17/2002
K211748 Selux Diagnostics, Inc Selux AST System; Model AST Gen 1.0 04/19/2023
K211759 Selux Diagnostics, Inc. Selux AST System; Model AST Gen 1.0 01/18/2023
K092919 SIEMENS HEALTHCARE DIAGNOSTICS MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 10/23/2009
K033064 TRINITY BIOTECH USA MYCOPLASMA IGG 11/26/2003


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