K150236 |
02/02/2015 |
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) |
THERMO FISHER SCIENTIFIC |
K150556 |
03/04/2015 |
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) |
THERMO FISHER SCIENTIFIC |
K230935 |
04/03/2023 |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) |
Thermo Fisher Scientific |
K090968 |
04/06/2009 |
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K140985 |
04/16/2014 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
K141000 |
04/18/2014 |
SENSITITRE SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
K221198 |
04/26/2022 |
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL |
Thermo Fisher Scientific |
K231433 |
05/17/2023 |
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL |
Thermo Fisher Scientific |
K211539 |
05/18/2021 |
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL |
Thermo Fisher Scientific |
K141651 |
06/20/2014 |
SENSITITRE SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
K171870 |
06/22/2017 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 û 8 ug/mL |
Thermo Fisher Scientific |
K221899 |
06/30/2022 |
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml |
Thermo Fisher Scientific |
K231994 |
07/05/2023 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL |
Thermo Fisher Scientific |
K191914 |
07/17/2019 |
Thermo Scientific Sensititre ARIS HiQ System |
Thermo Fisher Scientific |
K191918 |
07/18/2019 |
Thermo Scientific Sensititre ARIS HiQ System |
Thermo Fisher Scientific |
K181946 |
07/20/2018 |
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL |
Thermo Fisher Scientific |
K172274 |
07/28/2017 |
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8╡g/mL |
Thermo Fisher Scientific |
K142151 |
08/06/2014 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
K172454 |
08/14/2017 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL |
Thermo Fisher Scientific |
K192250 |
08/19/2019 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL |
Thermo Fisher Scientific |
K142338 |
08/21/2014 |
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) |
THERMO FISHER SCIENTIFIC |
K202612 |
09/09/2020 |
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) |
Thermo Fisher Scientific |
K062816 |
09/20/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K162620 |
09/20/2016 |
Remel Spectra ESBL |
REMEL, INC. |
K152774 |
09/25/2015 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL |
THERMO FISHER SCIENTIFIC |
K192729 |
09/27/2019 |
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml |
Thermo Fisher Scientific |
K182797 |
10/01/2018 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 ╡g/mL |
Thermo Fisher Scientific |
K173209 |
10/02/2017 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL |
Thermo Fisher Scientific |
K193024 |
10/30/2019 |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL |
Thermo Fisher Scientific |
K183033 |
11/01/2018 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml |
Thermo Fisher Scientific |
K143288 |
11/17/2014 |
Sensititre Susceptibility plates |
THERMO FISHER SCIENTIFIC |
K143381 |
11/25/2014 |
Sensititre Susceptibility Plates |
Thermo Fisher Scientific |
K183324 |
11/30/2018 |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL |
Thermo Fisher Scientific |
K103532 |
12/01/2010 |
AUTOREADER 2 |
TREK DIAGNOSTIC SYSTEMS |
K093741 |
12/04/2009 |
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, LTD. |
K133773 |
12/12/2013 |
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM |
Thermo Fisher Scientific |
K143526 |
12/12/2014 |
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) |
Thermo Fisher Scientific |
K133847 |
12/18/2013 |
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
K193538 |
12/20/2019 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ╡g/ml |
Thermo Fisher Scientific |
K203741 |
12/22/2020 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml |
Thermo Fisher Scientific |
K223844 |
12/22/2022 |
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) |
Thermo Fisher Scientific |
K110331 |
02/03/2011 |
SENSITITRE AIM (TM) |
TREK DIAGNOSTIC SYSTEMS, LTD. |
K110583 |
03/01/2011 |
SENSITITRE OPTIREAD |
TREK DIAGNOSTIC SYSTEMS, LTD. |
K020762 |
03/07/2002 |
GATIFLOXIN |
TREK DIAGNOSTIC SYSTEMS, INC. |
K060621 |
03/08/2006 |
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- |
TDS HOLDINGS INC. |
K040619 |
03/09/2004 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K020859 |
03/18/2002 |
CEFOTAXIME |
TREK DIAGNOSTIC SYSTEMS, INC. |
K060783 |
03/22/2006 |
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL |
TREK DIAGNOSTIC SYSTEMS, INC. |
K001036 |
03/31/2000 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN) |
TREK DIAGNOSTIC SYSTEMS, INC. |
K001035 |
03/31/2000 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN) |
TREK DIAGNOSTIC SYSTEMS, INC. |
K040846 |
04/01/2004 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K081063 |
04/14/2008 |
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS |
TREK DIAGNOSTIC SYSTEMS, INC. |
K031545 |
05/16/2003 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K021627 |
05/17/2002 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K001558 |
05/19/2000 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN) |
TREK DIAGNOSTIC SYSTEMS, INC. |
K001573 |
05/22/2000 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K111429 |
05/23/2011 |
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... |
TREK DIAGNOSTIC SYSTEMS, LTD. |
K991810 |
05/27/1999 |
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST |
TREK DIAGNOSTIC SYSTEMS, INC. |
K972756 |
05/30/1997 |
MODIFICATION OF EST CULTURE SYSTEM II - MYCO |
ACCUMED INTL., INC. |
K081520 |
05/30/2008 |
SENSITITRE VIZION |
TREK DIAGNOSTIC SYSTEMS, INC. |
K041534 |
06/08/2004 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL |
TREK DIAGNOSTIC SYSTEMS, LTD. |
K111615 |
06/10/2011 |
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS |
K011803 |
06/11/2001 |
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K021997 |
06/19/2002 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K012151 |
07/10/2001 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K062022 |
07/17/2006 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K062190 |
07/31/2006 |
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K032382 |
08/01/2003 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K052091 |
08/02/2005 |
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS |
TREK DIAGNOSTIC SYSTEMS, INC. |
K012565 |
08/09/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K022775 |
08/09/2002 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K022656 |
08/09/2002 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K112276 |
08/09/2011 |
VIZION |
TREK DIAGNOSTIC SYSTEMS |
K092445 |
08/10/2009 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, LTD. |
K012921 |
08/31/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K062681 |
09/08/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, LTD. |
K062722 |
09/12/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K013075 |
09/14/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K983244 |
09/16/1998 |
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) |
TREK DIAGNOSTIC SYSTEMS, INC. |
K062783 |
09/18/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K983301 |
09/21/1998 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN |
ACCUMED INTL., INC. |
K983306 |
09/21/1998 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN |
ACCUMED INTL., INC. |
K983309 |
09/21/1998 |
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN |
ACCUMED INTL., INC. |
K983310 |
09/21/1998 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN |
ACCUMED INTL., INC. |
K062839 |
09/21/2006 |
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K062841 |
09/22/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K013195 |
09/25/2001 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K013368 |
10/11/2001 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K013580 |
10/29/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K013925 |
11/14/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K053243 |
11/21/2005 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K103456 |
11/24/2010 |
THE SENSITITRE AIM |
TREK DIAGNOSTIC SYSTEMS |
K073424 |
12/05/2007 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K083606 |
12/05/2008 |
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K003834 |
12/12/2000 |
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS |
TREK DIAGNOSTIC SYSTEMS, INC. |
K003868 |
12/14/2000 |
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS |
TREK DIAGNOSTIC SYSTEMS, INC. |
K984489 |
12/17/1998 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
ACCUMED INTL., INC. |
K073558 |
12/19/2007 |
SENSITITRE 18-24 SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K965190 |
12/24/1996 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE |
ACCUMED INTL., INC. |
K014259 |
12/26/2001 |
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K014258 |
12/26/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K073653 |
12/26/2007 |
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
K004045 |
12/29/2000 |
SUSCEPTIBILITY TEST PANEL |
TREK DIAGNOSTIC SYSTEMS, INC. |
K024353 |
12/30/2002 |
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
K024357 |
12/30/2002 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |