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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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12-Panel DOA Dual Chamber Cup, AMP300/BAR200/BUP10/BZO200/ COC150/MDMA/MET300/MTD300/OPI300/OXY/TCA/THC, 25tests/kit
CHEMTRON BIOTECH INC
712L07D
In Commercial Distribution

  • 00850019007701 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MET500/MTD/OPI300/OXY/PCP/PPX/TCA/THC - Chemtrue, 25tests/kit
CHEMTRON BIOTECH INC
712M03-CT
In Commercial Distribution

  • 00850019007619 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 12, COC/THC/MET/OPI2000/AMP/MDMA/BAR/BZO/MTD/PPX/OXY/BUP - Clia Waived, 25tests/kit
CHEMTRON BIOTECH INC
C-61205D
In Commercial Distribution

  • 00850019007596 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 13 CLIA-Waived, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/TCA/THC, 25pcs/kit
CHEMTRON BIOTECH INC
C31303D
In Commercial Distribution

  • 00850019007473 ()
C31303D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Screen Cup Tests, AMP/BAR/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/TCA/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712L03
In Commercial Distribution

  • 00850019007428 ()
712L03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel Drug Screen Dip Card Tests, THC/COC/MOR300/MET/AMP/PCP/BZO/BAR/MTD/OXY/MDMA, 25pcs/kit
CHEMTRON BIOTECH INC
711K01
In Commercial Distribution

  • 00850019007398 ()
711K01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BluRapids Concise CLIA Waived Drug Cup; 12-Panel; AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/THC
MERCEDES MEDICAL, LLC
TNR CDOA6125M
In Commercial Distribution

  • 10850011007294 ()
  • 00850011007297 ()
  • 00850011007280 ()
TNR CDOA6125M

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Tanner Scientific CLIA waived 13 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR DOA13A
In Commercial Distribution

  • 20850011007130 ()
  • 10850011007133 ()
  • 00850011007136 ()
TNR DOA13A

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Tanner Scientific CLIA waived Drug Cup; 12Panel AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/THC
MERCEDES MEDICAL, LLC
TNR DOA12A
In Commercial Distribution

  • 20850011007123 ()
  • 10850011007126 ()
  • 00850011007129 ()
TNR DOA12A

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, liquid chromatography
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR CDOA7125
In Commercial Distribution

  • 00850011007082 ()
  • 10850011007089 ()
  • 20850011007086 ()
TNR CDOA7125

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-300/OXY/ PCP/THC
MERCEDES MEDICAL, LLC
TNR CDOA6125
In Commercial Distribution

  • 00850011007068 ()
  • 10850011007065 ()
  • 20850011007062 ()
TNR CDOA6125

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
DOA 8 in 1 Test Dip Card, Sealed Pouch, CLIA Waived, AMP/COC150/mAMP500/MDMA/OPI/OXY/PCP/THC
W.H.P.M. INC.
W3684
In Commercial Distribution

  • 00841824104525 ()
  • 00841824104532 ()
W3684P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 8 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived AMP/BUP/BZO/COC/EDDP/MDMA/MOR/THC
W.H.P.M. INC.
W1384
In Commercial Distribution

  • 00841824104044 ()
  • 00841824104051 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived AMP/BZO/COC/mAMP/MOR/PCP/THC
W.H.P.M. INC.
ECOII-4574
In Commercial Distribution

  • 00841824103986 ()
  • 00841824103993 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 8 in 1 ECO II Cup, 25Pcs/Box, CLIA Waived AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC
W.H.P.M. INC.
ECOII-984
In Commercial Distribution

  • 00841824103849 ()
  • 00841824103856 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 8 in 1 ECO II Cup, 25Pcs/Box, CLIA Waived AMP/BARB/BZO/COC/mAMP/OPI/PCP/THC
W.H.P.M. INC.
ECOII-184
In Commercial Distribution

  • 00841824103818 ()
  • 00841824103832 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/PCP/THC
W.H.P.M. INC.
ECOII-874
In Commercial Distribution

  • 00841824103375 ()
  • 00841824103405 ()
ECOII-874

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO Cup W/AD, 25Pcs/Box Clia Waived AMP/COC/mAMP/MOR/THC/PH-SG-OX
W.H.P.M. INC.
WECCUP454 W/AD
In Commercial Distribution

  • 00841824103269 ()
  • 00841824103276 ()
WECCUP454 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 9 in 1 Test Dipcard, 25Pcs/Box, Clia Waived AMP/BUP/BZO/COC/mAMP/MOR/MTD/OXY/THC
W.H.P.M. INC.
W1094
In Commercial Distribution

  • 00841824102903 ()
  • 00841824100695 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 9 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/THC
W.H.P.M. INC.
W194
In Commercial Distribution

  • 00841824102897 ()
  • 00841824100688 ()
W194

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO Cup W/AD, 25Pcs/Box Clia Waived AMP/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
WECCUP254 W/AD
In Commercial Distribution

  • 00841824101944 ()
  • 00841824101357 ()
WECCUP254W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box Clia Waived AMP/COC/mAMP/MDMA/OPI/PCP/THC
W.H.P.M. INC.
ECOII-674
In Commercial Distribution

  • 00841824101739 ()
  • 00841824101746 ()
ECOII-674

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/OXY/THC
W.H.P.M. INC.
ECOⅡ-174
In Commercial Distribution

  • 00841824101166 ()
  • 00841824101531 ()
ECOⅡ-174

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO Cup W/AD, 25Pcs/Box Clia Waived COC/mAMP/OPI/PCP/THC/PH-SG-OX
W.H.P.M. INC.
WECCUP354 W/AD
In Commercial Distribution

  • 00841824101074 ()
  • 00841824101432 ()
WECCUP354 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Home Drug Test 14 Panel THC/COC/PCP/mAMP/AMP/MDMA/TCA/BAR/BZO/MTD/OXY/PPX/BUP/OPI
RITE AID CORPORATION
8024512
In Commercial Distribution

  • 00011822001670 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • 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
  • Propoxyphene IVD, reagent
  • Nortriptyline IVD, reagent
DOA 8 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, AMP500/BUP/BZO/COC150/MTD/OPI/OXY/THC
W.H.P.M. INC.
W3884
In Commercial Distribution

  • 00841824104761 ()
  • 10841824104768 ()
W3884

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Multi-Drug of Abuse Urine Cup Test AMP BAR BUP BZD COC MET MOR300 MTD OXY PCP TCA THC XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-4680
In Commercial Distribution

  • 00796918002440 ()
  • 10796918002447 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) AMP COC MET MOR PCP THC MDMA(XTC)
ALFA SCIENTIFIC DESIGNS, INC.
03-4703OT
In Commercial Distribution

  • 10796918002065 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drug of Abuse Urine Cup Test AMP BAR BZD COC MET MOR/OPI MTD PCP TCA THC XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-4570
In Commercial Distribution

  • 10796918001518 ()
  • 00796918001511 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET, MOR, MTD, PCP, PPX, TCA, THC, XTC wADU
ALFA SCIENTIFIC DESIGNS, INC.
03-3957
In Commercial Distribution

  • 10796918001433 ()
  • 00796918001436 ()


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