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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an in vitro test to determine the susceptibility of clinically significant yeast to antifungal agents
BIOMERIEUX , INC.
VITEK® 2 AST-YS05
Not in Commercial Distribution

  • 03573026373047 ()
  • 03573026529758 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
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
BIOMERIEUX , INC.
VITEK®2 AST-ST01
Not in Commercial Distribution

  • 03573026345334 ()
  • 03573026529741 ()


  • General-microorganism antimicrobial susceptibility culture medium IVD
The VITEK® 2 ANC Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important anaerobic bacteria and coryneform bacteria
BIOMERIEUX , INC.
VITEK® 2 ANC
In Commercial Distribution

  • 03573026144364 ()
  • 03573026529727 ()


  • Multiple anaerobic bacteria species culture isolate identification IVD, kit
The VITEK® 2 NH Identification Card is intended for use with the VITEK 2 Systems for ID of clinically important Neisseria, Haemophilus and other fastidious GN bacteria
BIOMERIEUX , INC.
VITEK® 2 NH
In Commercial Distribution

  • 03573026144357 ()
  • 03573026529710 ()


  • Multiple Haemophilus/Neisseria bacteria species culture isolate identification IVD, kit
The VITEK® 2 YST Identification Card is intended for use with the VITEK 2 to determine ID of clinically important yeast and yeast-like organisms
BIOMERIEUX , INC.
VITEK® 2 YST
In Commercial Distribution

  • 03573026131937 ()
  • 03573026529697 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit
Reagents associated to API 20 E™ (20 100/20 160), API® 10 S (10 100), API® 20 NE (20 050), API® Staph (20 500), API® Coryne (20 900), API® Campy (20 800), ID 32 STAPH (32 500), rapid ID 32 A (32 300)
BIOMERIEUX SA
70442
In Commercial Distribution

  • 03573026099671 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
VP1 VP2 are reagents associated to API 20 E™ (20 100/20 160), RapiD 20 E™ (20 701), API® Staph (20 500), API® 20 Strep (20 600)
BIOMERIEUX SA
70422
In Commercial Distribution

  • 03573026099626 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent
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.
BIOMERIEUX , INC.
27415R
In Commercial Distribution

  • 03573026220631 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
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.
BIOMERIEUX , INC.
27415
In Commercial Distribution

  • 03573026220624 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
VITEK® 2 COMPACT 60 is an automated system that performs bacterial ID & AST. A total of 60 ID and/or AST cards can be processed simultaneously per run.
BIOMERIEUX , INC.
27560R
In Commercial Distribution

  • 03573026147501 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD
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