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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X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the left and ceph arm on the left
DE GÖTZEN SRL
XMT PAN L CEPH L
Not in Commercial Distribution

  • D804W09002320 ()
W0900232

  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the left and ceph arm on the right
DE GÖTZEN SRL
XMT PAN L CEPH R
Not in Commercial Distribution

  • D804W09000090 ()
W0900009

  • Stationary panoramic/tomographic dental x-ray system, digital
Healgen (DrugConfirm) - 14 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-1145
In Commercial Distribution

  • 00895330002592 ()


  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Nortriptyline IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent
Identify Health 6 Panel Drug Screen Test Cup - CLIA Waived AMP500, COC150, MET500, OPI300, PCP25 THC50 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-H6-3-AZ25
In Commercial Distribution

  • 00850013036004 ()
  • 10850013036001 ()
ID-H6-3-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - BUP10, BZO300, COC150, MTD300, MOR300, OXY100 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-US6-BUP
In Commercial Distribution

  • 00850013035144 ()
  • 10850013035141 ()
ID-US6-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 10 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ10
In Commercial Distribution

  • 20850721007680 ()
  • 10850721007683 ()
  • 00850721007686 ()
ID-CP10-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home TM Drug Screening Test Cards 9 Panel Drug Test Card AMP/BUP/BZO/COC/mAMP/MOP/MTD/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
UCP9-DIP-B-394
In Commercial Distribution

  • 20850721007529 ()
  • 10850721007522 ()
  • 00850721007525 ()
UCP9-DIP-B-394

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 10 panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ25
In Commercial Distribution

  • 20850721007499 ()
  • 10850721007492 ()
  • 00850721007495 ()
ID-CP10-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 10 panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ5
In Commercial Distribution

  • 20850721007482 ()
  • 10850721007485 ()
  • 00850721007488 ()
ID-CP10-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single/Multi DOA Panel MOR 2000 (Urine)- OXY100, MDMA500, COC300, BZO300, EDDP300, BUP10, MET1000, OPI2000, AMP1000, THC50-25 tests/ kit
BTNX Inc
D10.43-1P29-25
In Commercial Distribution

  • 00722066008256 ()
  • 10722066008253 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 5 Panel Saliva Test Cup E/I Screening (D5.39-2FC1E)- AMP50, COC20, MET50, OPI40, PCP10. For employment and insurance testing.
BTNX Inc
D5.39-2FC1E
In Commercial Distribution

  • 00722066006771 ()
  • 10722066006778 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 5 Panel Saliva Test Cup E/I Screening (D5.2-2FC1E)- TAMP50, COC20, OPI40, PCP10, THC40. For employment and insurance testing.
BTNX Inc
D5.2-2FC1E
In Commercial Distribution

  • 00722066006764 ()
  • 10722066006761 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 5 Panel Saliva Test Cup E/I Screening (D5.1.1-2FC1E)-THC40 COC20 AMP50 MET50 OPI40. For employment and insurance testing.
BTNX Inc
D5.1.1-2FC1E
In Commercial Distribution

  • 10722066006617 ()
  • 00722066006610 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 12 Panel Cup - KCUR920092 AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MTD300/OPI300/OXY100/PCP25/THC50 (SG/CR/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920092
In Commercial Distribution

  • 00817815021171 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 panel Cup - KCUR920083 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920083
In Commercial Distribution

  • 00817815021119 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CRL STAT 10 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

  • 00817815020655 ()
  • 00817815020662 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen 9 Panel E-Z Split Key Cup with Adulterants (Oxidants/Creatinine/pH)+<COC>+<AMP>+(MDMA/MTD)+(BZO/BAR)+(MET/OPI/PCP)
Instant Technologies, Inc.
DUE-197-341
In Commercial Distribution

  • 10817405024077 ()
  • 00817405024070 ()
DUE-197-341

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® Multi-Panel Urine Test (10 Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC), 25T/Box
WONDFO USA CO., LTD.
DWDOA-3104-25BX-A
In Commercial Distribution

  • 10816862024026 ()
  • 00816862024029 ()
  • 00816862024036 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 9 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MOR/MTD/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2397-0-A
In Commercial Distribution

  • 00816036025494 ()
  • 00816036025487 ()
SCP-2397-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/ + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STAII-03107-0-A
In Commercial Distribution

  • 00816036025463 ()
  • 00816036025456 ()
STAII-03107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel CLIA Waived Test Cup, with Adulterants 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC +pH, OX, CR.
MICRO DISTRIBUTING, L.C
STATII-4267-0-A
In Commercial Distribution

  • 00816036025401 ()
  • 00816036025418 ()
STATII-4267-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-41107-0-A
In Commercial Distribution

  • 00816036025111 ()
  • 00816036025272 ()
STATⅡ-41107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-12107-0-A
In Commercial Distribution

  • 00816036025081 ()
  • 00816036025241 ()
STATⅡ-12107-0-A

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

  • 00816036021687 ()
  • 00816036021694 ()
FST-71127

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (OXY/MDMA)+ (PCP/AMP)+COC150+MET500+MTD+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9CM5
Not in Commercial Distribution

  • 00816565020335 ()
IMCA-9CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 panel test cup, (COC/THC)+(OXY/MDMA)+AMP+BZO+MET1000+MTD+OPI2000 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-9A
Not in Commercial Distribution

  • 00816565020328 ()
IMCA-9A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/MTD/OPI2000/OXY with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)
AMEDITECH INC.
IMCA-7MT-W
Not in Commercial Distribution

  • 00816565020243 ()
IMCA-7MT-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 10-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1790UVB-NB
In Commercial Distribution

  • B2191790UVBNB0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 8-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1780UVB-NB
In Commercial Distribution

  • B2191780UVBNB0 ()


  • Ultraviolet phototherapy unit, home-use
  • Ultraviolet phototherapy unit, professional
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 1000-Series 6-foot 6-BULB UVB-Narrowband Full Body Panel. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema).
Solarc Systems Inc
1760UVB-NB
In Commercial Distribution

  • B2191760UVBNB0 ()


  • Ultraviolet phototherapy unit, professional
  • Ultraviolet phototherapy unit, home-use
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