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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MAJ-1868 ScopeGuide Receiver Dish
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1868
In Commercial Distribution

  • 04953170305689 ()


  • Gastrointestinal catheter/endoscope tracking system sensor, bedside
Stent System
BOSTON SCIENTIFIC CORPORATION
M00574660
In Commercial Distribution

  • 08714729820550 ()

  • 10 mm Diameter
  • 40 mm Length


  • Ophthalmic cryosurgical system control unit
No Description
OXOID LIMITED
MB1588A
In Commercial Distribution

  • 05032384128013 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1561A
In Commercial Distribution

  • 05032384128006 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1133A
In Commercial Distribution

  • 05032384127979 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
No Description
OXOID LIMITED
MB1132A
In Commercial Distribution

  • 05032384127962 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
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
No Description
TREK DIAGNOSTIC SYSTEMS LIMITED
GNID
In Commercial Distribution

  • M578GNID2 ()
  • M578GNID0 ()


  • Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit
No Description
TREK DIAGNOSTIC SYSTEMS LIMITED
GPID
In Commercial Distribution

  • M578GPID2 ()
  • M578GPID0 ()


  • Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit
Kit Crystal Rapid Gram-Positive Id
BECTON, DICKINSON AND COMPANY
245250
Not in Commercial Distribution

  • 30382902452509 ()
  • 00382902452508 ()
245250

  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
BD BBL™ Crystal™ GP Gram-Positive ID System
BECTON, DICKINSON AND COMPANY
245240
Not in Commercial Distribution

  • 30382902452400 ()
  • 00382902452409 ()
245240

  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
BD BBL™ Crystal™ Enteric/ID Inoculum Fluid
BECTON, DICKINSON AND COMPANY
245029
Not in Commercial Distribution

  • 30382902450291 ()
  • 00382902450290 ()
245029

  • Multiple gram negative bacteria species culture isolate identification IVD, kit
BD BBL™ Crystal™ E/NF
BECTON, DICKINSON AND COMPANY
245000
Not in Commercial Distribution

  • 30382902450000 ()
  • 00382902450009 ()
245000

  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Neg ID Panel Type 2
Beckman Coulter, Inc.
B1017-27
In Commercial Distribution

  • 15099590657604 ()
  • 05099590657607 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Pos ID Panel Type 3
Beckman Coulter, Inc.
B1017-221
In Commercial Distribution

  • 15099590657581 ()
  • 05099590657584 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
MicroScan Rapid Pos ID Panel Type 2
Beckman Coulter, Inc.
B1017-166
In Commercial Distribution

  • 15099590657338 ()
  • 05099590657331 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
MicroScan Rapid Neg ID Panel Type 4
Beckman Coulter, Inc.
B1017-165
In Commercial Distribution

  • 15099590657321 ()
  • 05099590657324 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Rapid Neg ID Panel Type 3
Beckman Coulter, Inc.
B1017-110
In Commercial Distribution

  • 15099590657239 ()
  • 05099590657232 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan 10% Ferric Chloride - 250ml
Beckman Coulter, Inc.
B1015-48
In Commercial Distribution

  • 15099590655884 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 0.5% N, N-Dimethylalphanaphthylamine - 250mL
Beckman Coulter, Inc.
B1015-45
In Commercial Distribution

  • 15099590655860 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 0.8% Sulfanilic Acid - 250ml
Beckman Coulter, Inc.
B1015-44
In Commercial Distribution

  • 15099590655853 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
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