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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No Description
OXOID LIMITED
MB1131A
In Commercial Distribution

  • 05032384127955 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1082A
In Commercial Distribution

  • 05032384127917 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1128A
In Commercial Distribution

  • 05032384127498 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GPID
In Commercial Distribution

  • 00848838074363 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
PLATE DRY CLI GRAM+ ID AUTO -A semi-quantitative test intended for the automated identification of Gram negative bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GNID
In Commercial Distribution

  • 00848838074325 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
VITEK® 2 GP Identification Card is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms
BIOMERIEUX , INC.
VITEK® 2 GP
In Commercial Distribution

  • 03573026131920 ()
  • 03573026529994 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
The VITEK® 2 GN Identification Card is intended for use with the VITEK 2 to determine ID of clinically important Gram negative bacteria
BIOMERIEUX , INC.
VITEK® 2 GN
In Commercial Distribution

  • 03573026131913 ()
  • 03573026529987 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
Codebook Crystal Rgp Manual
BECTON, DICKINSON AND COMPANY
245041
Not in Commercial Distribution

  • 00382902450412 ()
245041

  • Microorganism identification analyser IVD, manual
Codebook Crystal Gram-Positive Manual
BECTON, DICKINSON AND COMPANY
245037
Not in Commercial Distribution

  • 00382902450375 ()
245037

  • Microorganism identification analyser IVD, manual
BD BBL™ CRYSTAL™ Identification Systems Enteric / Nonfermenter
BECTON, DICKINSON AND COMPANY
245002
Not in Commercial Distribution

  • 00382902450023 ()
245002

  • Microorganism identification analyser IVD, manual
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