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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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A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, and Cocaine drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
601643
Not in Commercial Distribution

  • 10690286000244 ()
  • 00690286000247 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The ORLocate Components Pack contains the ORLocate Locator, ORLocate HoveRead, ORLocate Reader Box, and Advantech Medical Panel PC used with the ORLocate Sponge System.
STERIS CORPORATION
ORLocate Components Pack
In Commercial Distribution

ORL10017049

  • Radio-frequency identification reader
The ORLocate Components Pack contains the ORLocate Locator, ORLocate HoveRead, ORLocate Reader Box, and Advantech Medical Panel PC used with the ORLocate Sponge System.
Steris Corporation
ORLocate Components Pack
Not in Commercial Distribution

  • 00724995220631 ()
ORL10017049

  • Radio-frequency identification reader
The E-Series High Density Dual Light, Dual Flat Panel Monitor, No Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214265 ()
LEH14NCNDT

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The E-Series High Density Dual Light, Dual Flat Panel Monitor, 20-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214258 ()
LEH14NC02T

  • Medical monitor/light mount
  • Operating room light
  • Operating room light system
The E-Series High Density Dual Light, Dual Flat Panel Monitor, 13-inch Drop Tube, No Camera, Tandem is used with the HarmonyAIR E-Series Lighting System.
STERIS CORPORATION
E-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995214241 ()
LEH14NC01T

  • Operating room light
  • Operating room light system
  • Medical monitor/light mount
Identify®Diagnostics Drug Test Cards 7 Panel Drug Test Card BUP/BZO/COC/MET/MOP/OXY/THC with Adulteration strip (OX/CRE/pH)
MEDICAL DISTRIBUTION GROUP INC
ID-CP7-DIP-ADULT-AZ10
In Commercial Distribution

  • 20850721007772 ()
  • 10850721007775 ()
  • 00850721007778 ()
ID-CP7-DIP-ADULT-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify®Diagnostics Drug Test Cards 7 Panel Drug Test Card BUP/BZO/COC/MET/MOP/OXY/THC with Adulteration strip (OX/CRE/pH)
MEDICAL DISTRIBUTION GROUP INC
ID-CP7-DIP-ADULT-AZ5
In Commercial Distribution

  • 20850721007765 ()
  • 10850721007768 ()
  • 00850721007761 ()
ID-CP7-DIP-ADULT-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
dentify Diagnostics USA 8 Panel Drug Test Cup CLIA Waived - 3.0mm Test Strip AMP500, BUP10, BZO300, COC150, EDDP300, MET500, MOP300, OXY100 25 Test/Box
MEDICAL DISTRIBUTION GROUP INC
ID-US8-1
In Commercial Distribution

  • 00850013035151 ()
  • 10850013035158 ()
ID-US8-1-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-8124-RCN
In Commercial Distribution

  • 20817038021785 ()
  • 10817038021788 ()
  • 00817038021781 ()
U-CUP-8124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-9124-RCN
In Commercial Distribution

  • 20817038021631 ()
  • 10817038021634 ()
  • 00817038021637 ()
U-CUP-9124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/PCP/AMP
UCP BIOSCIENCES, INC.
U-CUP-3124-RCN
In Commercial Distribution

  • 20817038021600 ()
  • 10817038021603 ()
  • 00817038021606 ()
U-CUP-3124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-8124-RCN
In Commercial Distribution

  • 20817038021594 ()
  • 10817038021597 ()
  • 00817038021590 ()
U-CUP-8124-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 12 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MDMA/MOP/MTD/OXY/PCP/PPX/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-51127-0-A
In Commercial Distribution

  • 00816036027139 ()
  • 00816036026637 ()
SCP-51127-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 PANEL CLIA WAIVED ROUND CUP AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,PPX,TCA,THC SVT (Cr, ph, S.G.)
Instant Technologies, Inc.
ABTDUAW114702B
In Commercial Distribution

  • 30817405023432 ()
  • 00817405023431 ()
  • 10817405023438 ()
ABTDUAW114702B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/PCP/BAR/BZO/MDMA/MTD)
Instant Technologies, Inc.
USSCupA-10M
In Commercial Distribution

USSCupA-10M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (COC/OPI300/AMP/OXY/BZO/THC)
Instant Technologies, Inc.
I-DXP-167-02
In Commercial Distribution

  • 00817405020362 ()
I-DXP-167-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugCheck Waive 12 Panel Cup Test, (BZO/BAR)+(COC/THC)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP) With Cr, Ni, pH, Bl, S.G.
EXPRESS DIAGNOSTICS INT'L, INC.
DCC-81205-5
Not in Commercial Distribution

  • B298DCC8120550 ()
DCC-81205-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugCheck Waive 12 Panel Cup Test, (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G
EXPRESS DIAGNOSTICS INT'L, INC.
DC 81210-5
Not in Commercial Distribution

  • B298DC8121050 ()
DC 81210-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel DOA Cup, AMP300/BZO200/BUP/COC150/MDMA/MET300/MTD/MOR/OXY/THC/FYL5/A-strips(Cr/SG/Ox)/(Ni/pH/Gl), 25tests/kit
CHEMTRON BIOTECH INC
712K03A-G
In Commercial Distribution

  • 00812203030728 ()


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