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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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
MicroScan 40% Potassium Hydroxide - 250ml
Beckman Coulter, Inc.
B1015-43
In Commercial Distribution

  • 15099590655846 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Kovac's Reagent - 250ml
Beckman Coulter, Inc.
B1015-41
In Commercial Distribution

  • 15099590655822 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Peptidase - 250ml
Beckman Coulter, Inc.
B1015-30
In Commercial Distribution

  • 15099590655808 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit
MicroScan Rapid Indole Reagent-F
Beckman Coulter, Inc.
B1015-17
In Commercial Distribution

  • 15099590655709 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan HNID Indole Reagent - 30ml
Beckman Coulter, Inc.
B1015-15
In Commercial Distribution

  • 15099590655686 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Peptidase - 30ml
Beckman Coulter, Inc.
B1012-30B
In Commercial Distribution

  • 15099590655495 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit
MicroScan 10% Ferric Chloride - 30ml
Beckman Coulter, Inc.
B1010-48A
In Commercial Distribution

  • 15099590655259 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 0.5% N, N-Dimethylalphanaphthylamine - 30mL
Beckman Coulter, Inc.
B1010-45A
In Commercial Distribution

  • 15099590655242 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 0.8% Sulflanilic Acid - 30ml
Beckman Coulter, Inc.
B1010-44A
In Commercial Distribution

  • 15099590655235 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan 40% Potassium Hydroxide - 30ml
Beckman Coulter, Inc.
B1010-43A
In Commercial Distribution

  • 15099590655228 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Alpha Naphthol - 1.5g
Beckman Coulter, Inc.
B1010-42A
In Commercial Distribution

  • 15099590655211 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Kovac's Reagent - 30ml
Beckman Coulter, Inc.
B1010-41A
In Commercial Distribution

  • 15099590655204 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
MicroScan Mineral Oil - 250ml
Beckman Coulter, Inc.
B1010-40A
In Commercial Distribution

  • 15099590655198 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
MicroScan Mineral Oil - 60ml
Beckman Coulter, Inc.
B1010-40
In Commercial Distribution

  • 15099590655181 ()


  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
BD Phoenix™ NID
BECTON, DICKINSON AND COMPANY
448007
In Commercial Distribution

  • 00382904480073 ()
  • 30382904480074 ()
448007

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
BD Phoenix™ PID
BECTON, DICKINSON AND COMPANY
448008
In Commercial Distribution

  • 00382904480080 ()
  • 30382904480081 ()
448008

  • Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
ORTHO Ficin Panel System RESOLVE PANEL C Ficin Treated and Untreated 22X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
719410
In Commercial Distribution

  • 10758750003976 ()
719410

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
SHOWER & DISINFECTION PANEL, WHITE, US
Arjohuntleigh AB
BCA1204-04
In Commercial Distribution

  • 05055982707879 ()
BCA1204-04

  • Shower unit
Ready-Heat 4 Panel Heated Blanket
TECHTRADE, LLC
S4RHMD
In Commercial Distribution

  • 00850017905115 ()
  • 00850017905016 ()


  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
Ready-Heat 1 Panel Warming Wrap
TECHTRADE, LLC
S1RHSM
In Commercial Distribution

  • 00850017905139 ()
  • 00850017905009 ()


  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use
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