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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 A-Series Dual Light, Single Flat Panel Monitor, 20-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199517 ()
LAS02IN02A

  • Operating room light system
  • Operating room light
  • Medical monitor/light mount
The A-Series Dual Light, Single Flat Panel Monitor, 13-inch Drop Tube Adjustable is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Lighting System
In Commercial Distribution

  • 00724995199500 ()
LAS02IN01A

  • Medical monitor/light mount
  • Operating room light system
  • Operating room light
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
iScreen 8 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+<COC>+<PPX>+(MET/OPI/PCP)+(BZO/MTD/BAR)
Instant Technologies, Inc.
DUE-187-311
In Commercial Distribution

  • 10817405024107 ()
  • 00817405024100 ()
DUE-187-311

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Panel CLIA Waived Click Cup AMP1000, BAR300, BUP10, BZO300, COC300, EDDP300, MDMA500, MET1000, MOP300, MTD300, OXY100, PCP25, TCA1000, THC50
Instant Technologies, Inc.
ABTDOAW114701A
In Commercial Distribution

  • 30817405023876 ()
  • 00817405023875 ()
  • 10817405023872 ()
ABTDOAW114701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 PANEL 510(K) SQUARE CUP AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, PCP25, THC50 SVT (CR,OX,SG)
Instant Technologies, Inc.
ABTDUAK110701A
In Commercial Distribution

  • 30817405023487 ()
  • 00817405023486 ()
  • 10817405023483 ()
ABTDUAK110701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR/SG/OX) 5 Panel Drug Screen (AMP500/BZO300/COC150/MET500/OPI300)
Instant Technologies, Inc.
USSCupA-5E
In Commercial Distribution

  • 00817405020973 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8CM5
Not in Commercial Distribution

  • 00816565020281 ()
IMCA-8CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8BB
Not in Commercial Distribution

  • 00816565020267 ()
IMCA-8BB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-21107-0-A
In Commercial Distribution

  • 00816036027177 ()
  • 00816036026675 ()
SCP-21107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 8 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2387-0-A
In Commercial Distribution

  • 00816036027153 ()
  • 00816036026651 ()
SCP-2387-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 12 Panel Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-71127-0
In Commercial Distribution

  • 00816036025128 ()
  • 00816036025289 ()
STATⅡ-71127-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
CRL STAT10 panel Cup - KCUR920126 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/THC50(OX/SG/pH/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920126
In Commercial Distribution

  • 00817815021478 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 9 Panel Cup - KCUR920120 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25 (CR/NI/OX/PH/SG)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920120
In Commercial Distribution

  • 00817815021416 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 13 Panel Cup - KCUR920119 AMP1000/BAR 300/BUP10/BZO300/COC300/MAMP1000/MDMA500/MTD300/OPI2000/OXY100/PCP25/TCA1000/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920119
In Commercial Distribution

  • 00817815021386 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Cup-KCUR920115 AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50 (OX/SG/pH/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920115
In Commercial Distribution

  • 00817815021355 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920084
In Commercial Distribution

  • 00817815021140 ()


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