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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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The T2Biothreat Panel components used to load the patient sample to be run and that contains disposables and Lysis Reagent
T2 BIOSYSTEMS, INC.
90-11400
In Commercial Distribution

  • M70890114000 ()


  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
90-01794
Not in Commercial Distribution

  • M70890017940 ()


  • Multiple Candida species nucleic acid IVD, reagent
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC-G
In Commercial Distribution

  • D0692502MCCG0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC-C
In Commercial Distribution

  • D0692502MCCC0 ()


  • Dental delivery system
COMPACT CONTROL, PANEL MOUNT, 3 HP, MCC WITH CLEAN WATER SYSTEM; AIR-WATER SHUTOFF/REGULATOR KITS; ROUTING VALVE KIT; NO UC
Ls Enterprises, Inc.
2502MCC
In Commercial Distribution

  • D0692502MCC0 ()


  • Dental delivery system
X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the left
DE GÖTZEN SRL
XMT PAN 3D L
Not in Commercial Distribution

  • D804W09000100 ()
W0900010

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN CBCT version including one removable pan sensor and a CBCT sensor, with control panel on the right
DE GÖTZEN SRL
XMT PAN 3D R
Not in Commercial Distribution

  • D804W09000040 ()
W0900004

  • Cone beam computed tomography system, head/neck
  • Stationary panoramic/tomographic dental x-ray system, digital
Healgen (DrugConfirm) - 12 Panel AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50/Adulterants (CR/SG/OX)
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-6125A3C
In Commercial Distribution

  • 00895330002851 ()


  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
Healgen (DrugConfirm) - 14 Panel Dip Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-1145
In Commercial Distribution

  • 00895330002585 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Methadone IVD, reagent
  • Nortriptyline IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
Identify Health 5 Panel Drug Test Cup - CLIA Waived COC150/MET500/OPI300/OXY100/THC50 3mm Strip, 25 Tests Per Box
MEDICAL DISTRIBUTION GROUP INC
ID-H5-1
In Commercial Distribution

  • 00850013035038 ()
  • 10850013035127 ()
ID-H5-1

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