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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Triage® Micro Parasite Panel
ALERE SAN DIEGO, INC.
96100
Not in Commercial Distribution

  • 00893038002180 ()
96100

  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
Alere Triage® Cardio2 Panel
ALERE SAN DIEGO, INC.
97500EU
Not in Commercial Distribution

  • 00893038002814 ()
97500EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Alere Triage® Cardio3 Panel
ALERE SAN DIEGO, INC.
97400EU
Not in Commercial Distribution

  • 00893038002807 ()
97400EU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Calf Panel, Spacer Mesh, Large
Drive Devilbiss Healthcare
PCP-280L
In Commercial Distribution

  • 00822383940724 ()


  • Freestanding patient positioner, reusable
Calf Panel, Spacer Mesh, Medium
Drive Devilbiss Healthcare
PCP-280M
In Commercial Distribution

  • 00822383940717 ()


  • Freestanding patient positioner, reusable
Calf Panel, Spacer Mesh, Small
Drive Devilbiss Healthcare
PCP-280S
In Commercial Distribution

  • 00822383940700 ()


  • Freestanding patient positioner, reusable
iScreen MET Panel(Urine) 25T
Instant Technologies, Inc.
DMA-114
In Commercial Distribution

  • 30817405022473 ()
  • 00817405022472 ()
  • 10817405022479 ()
DMA-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MOP Panel(Urine) 25T
Instant Technologies, Inc.
DMO-114
In Commercial Distribution

  • 30817405022466 ()
  • 00817405022465 ()
  • 10817405022462 ()
DMO-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen OPI Panel(Urine) 25T
Instant Technologies, Inc.
DOP-114
In Commercial Distribution

  • 30817405022459 ()
  • 00817405022458 ()
  • 10817405022455 ()
DOP-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen TCA Panel(Urine) 25T
Instant Technologies, Inc.
DTC-114
In Commercial Distribution

  • 30817405022442 ()
  • 00817405022441 ()
  • 10817405022448 ()
DTC-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen COC Panel(Urine) 25T
Instant Technologies, Inc.
DCO-114
In Commercial Distribution

  • 30817405022435 ()
  • 00817405022434 ()
  • 10817405022431 ()
DCO-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen AMP Panel(Urine) 25T
Instant Technologies, Inc.
DAM-114
In Commercial Distribution

  • 30817405022428 ()
  • 00817405022427 ()
  • 10817405022424 ()
DAM-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen THC Panel(Urine) 25T
Instant Technologies, Inc.
DTH-114
In Commercial Distribution

  • 30817405022312 ()
  • 00817405022311 ()
  • 10817405022318 ()
DTH-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen OXY Panel(Urine) 25T
Instant Technologies, Inc.
DOX-114
In Commercial Distribution

  • 30817405022305 ()
  • 00817405022304 ()
  • 10817405022301 ()
DOX-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MTD Panel(Urine) 25T
Instant Technologies, Inc.
DMT-114
In Commercial Distribution

  • 30817405022299 ()
  • 00817405022298 ()
  • 10817405022295 ()
DMT-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen BZO Panel(Urine) 25T
Instant Technologies, Inc.
DBZ-114
In Commercial Distribution

  • 30817405022282 ()
  • 00817405022281 ()
  • 10817405022288 ()
DBZ-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MET500 Panel(Urine) 25T
Instant Technologies, Inc.
DMA-U114
In Commercial Distribution

  • 30817405022084 ()
  • 00817405022083 ()
  • 10817405022080 ()
DMA-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen COC150 Panel(Urine) 25T
Instant Technologies, Inc.
DCO-U114
In Commercial Distribution

  • 30817405022077 ()
  • 00817405022076 ()
  • 10817405022073 ()
DCO-U114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen BUP Panel(Urine) 25T
Instant Technologies, Inc.
DBU-114
In Commercial Distribution

  • 30817405021919 ()
  • 00817405021918 ()
  • 10817405021915 ()
DBU-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen PCP Panel(Urine) 25T
Instant Technologies, Inc.
DPC-114
In Commercial Distribution

  • 30817405021711 ()
  • 00817405021710 ()
  • 10817405021717 ()
DPC-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen MDMA Panel(Urine) 25T
Instant Technologies, Inc.
DMD-114
In Commercial Distribution

  • 30817405021483 ()
  • 00817405021482 ()
  • 10817405021489 ()
  • 00817405021123 ()
DMD-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen BAR Panel(Urine) 25T
Instant Technologies, Inc.
DBA-114
In Commercial Distribution

  • 30817405021476 ()
  • 00817405021475 ()
  • 10817405021472 ()
DBA-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
0.8% RESOLVE PANEL C 22X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902319
In Commercial Distribution

  • 10758750007691 ()
6902319

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
0.8% RESOLVE PANEL B 11X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902318
In Commercial Distribution

  • 10758750007684 ()
6902318

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
0.8% RESOLVE PANEL A 11X3ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
6902317
In Commercial Distribution

  • 10758750007677 ()
6902317

  • Antibody identification panel reagent red blood cell IVD, kit, agglutination
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HSEU
Not in Commercial Distribution

  • 00899722002719 ()
97000HSEU

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Live View Panel Version 1.4
Neurotronics, LLC
1.4
In Commercial Distribution

  • 00817111020816 ()


  • Bioelectrical signal analysis software
  • Sleep disorder interpretive software, professional-only
Live View Panel Version 1.3
Neurotronics, LLC
1.3
Not in Commercial Distribution

  • 00817111020786 ()


  • Bioelectrical signal analysis software
  • Sleep disorder interpretive software, professional-only
17X17 flat Panel Detector (CsI)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN253
In Commercial Distribution

  • 00817100020452 ()


  • Diagnostic x-ray digital imaging conversion system
17X17 Flat Panel Detector (GOS)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN252
In Commercial Distribution

  • 00817100020445 ()


  • Diagnostic x-ray digital imaging conversion system
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