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 (=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (=1->/=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 (=0.25->= 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 (=0.125 ->/=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 |