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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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8 Panel DOA Test Dipcard
Healgen Scientific Limited Liability Company
HDOA-285
In Commercial Distribution

  • 20816490020053 ()
  • 10816490020056 ()
  • 00816490020059 ()
HDOA-285

  • 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
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
Alere Triage® Cardiac Panel
ALERE SAN DIEGO, INC.
97000HS
Not in Commercial Distribution

  • 00893038002197 ()
97000HS

  • Multiple cardiac marker IVD, kit, fluorescent immunoassay
Triage® Micro Parasite Panel
ALERE SAN DIEGO, INC.
96100
Not in Commercial Distribution

  • 00893038002180 ()
96100

  • Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)
KIT, DOOR PANEL - BASIC - BLK
NORTH AMERICAN RESCUE, LLC
80-1166
In Commercial Distribution

  • 00842209119141 ()
80-1166

  • First aid kit, medicated
Negative Control for T2Bacteria Panel
T2 BIOSYSTEMS, INC.
85-08074
In Commercial Distribution

  • M70885080743 ()
  • M70883080760 ()

  • Total Volume: 4 Milliliter


  • Multiple bloodstream bacteria nucleic acid IVD, control
EMG USB Control Panel II
NATUS NEUROLOGY INCORPORATED
043281
In Commercial Distribution

  • 00382830063272 ()


  • Electromyograph
Endeavor CR Mini Control Panel
NATUS NEUROLOGY INCORPORATED
515-013400
In Commercial Distribution

  • 00382830041621 ()


  • Electromyograph
EQ 14 PANEL DRG TEST
WAL-MART STORES, INC.
663396990
In Commercial Distribution

  • 00194346098101 ()


  • Methamphetamine-specific IVD, reagent
  • Nortriptyline IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Barbiturate IVD, kit, rapid ICT, clinical
EQ 7 PANEL DRUG TEST
WAL-MART STORES, INC.
663495429
In Commercial Distribution

  • 00194346098095 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
Flat Panel Fluoroscopy Registration Fixture
GLOBUS MEDICAL, INC.
6203.2100
In Commercial Distribution

  • 00193982465155 ()


  • Robotic surgical navigation system
PANEL,MESH,REPLACEMENT FOR 13672,1
MEDLINE INDUSTRIES, INC.
MDT013672RM
In Commercial Distribution

  • 10888277417717 ()
MDT013672RM

  • Patient surgical drape, reusable
BD MAX™ Vaginal Panel
BECTON, DICKINSON AND COMPANY
443712
In Commercial Distribution

  • 00382904437121 ()
443712

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
PANEL 3 M-AMP/COC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020014
In Commercial Distribution

  • 10858904006218 ()
  • 00858904006211 ()
DOA-534-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 3 COC/M-AMP/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020009
In Commercial Distribution

  • 10858904006201 ()
  • 00858904006204 ()
DOA-234-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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