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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Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSCupA-10OM
Not in Commercial Distribution

  • 00817405020676 ()
PSCupA-10OM

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 12-Panel Card; 25 per box; AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
DWDOA-6125-25BX-A
In Commercial Distribution

  • 10816862026051 ()
  • 00816862026054 ()
  • 00816862026047 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup Compact without THC; AMP500,BAR,BUP,BZO,COC150,MDMA,MET500,MOP,MTD,OXY,PCP,PPX,TCA with 3AD
WONDFO USA CO., LTD.
CDOA-L9135NTA3
In Commercial Distribution

  • 10816862023296 ()
  • 00816862023299 ()
  • 00816862023305 ()
CDOA-L9135NTA3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC with CR/pH/S.G.
WONDFO USA CO., LTD.
CDOA-2135A3
In Commercial Distribution

  • 10816862026396 ()
  • 00816862026399 ()
  • 00816862026382 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST SplitCup-8+6 w. Adulteration Screen (pH/ S.G./ Oxidant/Nit/Glut/Creatinine) (AMP/BAR/BZO/COC/MAMP/OPI/PCP/THC/)
JANT PHARMACAL CORPORATION
DS208
In Commercial Distribution

  • 10763924208620 ()
  • 00763924208623 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Accutest SplitCup-6 with Adulteration Screen AMP (300), COC (150,) MDMA (500,) M-AMP (500,) OPI (2000,) THC (50.) + (Oxidants, SG, PH.)
JANT PHARMACAL CORPORATION
DS09AC625
In Commercial Distribution

  • 10763924009623 ()
  • 00763924009626 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST SplitCup-6+3 w. Adulteration Screen (pH/ S.G./ Oxidant) (AMP1000 /COC 300 /MET 1000/ OPI 2000/ PCP 25/ THC 50)
JANT PHARMACAL CORPORATION
DS08AC625
In Commercial Distribution

  • 10763924008626 ()
  • 00763924008629 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC,CR,PH,SG
Eterbio, Inc.
ETG011025
In Commercial Distribution

  • 06977469280189 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 Tests/Kit;12 Panel;AMP;BAR;BUP;BZO;COC;MDMA;MET;MOP;MTD;OXY;PCP;THC;CR;PH;SG
Eterbio, Inc.
ETG004025
In Commercial Distribution

  • 06977469280042 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UDOA-12CE-0712-01 (Ox/Cr/pH)+<BUP>+(OXY/PPX)+(mAMP/MOP/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)MULTI-DRUG previous (GTIN 10869419000233)
Quest Diagnostics
UDOA-12CE-0712-01
In Commercial Distribution

  • 00869419000236 ()
  • 30869419000237 ()
DUE-1127-051-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
QUIKSCREEN MULTI 6+1 DRUG CUP TEST - AMP 1000, BZD 300, COC 300, MET 1000, OPI 300, THC 50 + ALC
SYNTRON BIORESEARCH, INC.
65646-19
In Commercial Distribution

  • 20748349000292 ()
  • 10748349000295 ()
  • 00748349000298 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
QuikScreen Multi 7 Drug Cup Test - AMP 500, MDMA 500, COC 300, MET 500, OPI 300, MAD 300, THC 50
SYNTRON BIORESEARCH, INC.
60719
In Commercial Distribution

  • 20748349000131 ()
  • 10748349000134 ()
  • 00748349000137 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Morphine, Oxycodone, Propoxyphene, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.1-1G29-25
In Commercial Distribution

  • 00722066003701 ()
  • 00722066004159 ()
D12.1-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug One Step Cup (AMP/BAR/BUP/BZO/COC/MDMA/MTD/MET/OPI/OXY/THC/PCP) - 25 Tests/ kit are for the qualitative detection of Amphetamine, Barbiturate, Buprenorphine, Bezodiazepines, 3,4-Methylenedioxy-Methamphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.5-1T
In Commercial Distribution

  • 00722066003695 ()
  • 00722066004098 ()
D12.5-1T

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Platinum+ Click Cap Drug Cup, 12 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/THC, CLIA WAIVED
MERCEDES MEDICAL, LLC
MER MMDOAY6125
In Commercial Distribution

  • 10850011007720 ()
  • 00850011007723 ()
  • 00850011007570 ()
MER MMDOAY6125

  • 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
  • Methadone 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
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Platinum+ Click Cap Drug Cup, 12 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/THC, CLIA WAIVED
MERCEDES MEDICAL, LLC
MER HCDOAY6125
In Commercial Distribution

  • 00850011007334 ()
  • 00850011007327 ()
  • 00850011007310 ()
MER HCDOAY6125

  • 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
CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731989 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731972 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 14 Panel Drug Test Card (THC/COC/MOP300/AMP/MET/PCP/BZO/BAR/BUP/OXY/MDMA/MTD/TCA/EDDP)
Medical Disposables Corp
M-DOA-2145
In Commercial Distribution

  • 00860001731965 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10CT
Not in Commercial Distribution

  • 00858998006586 ()
PSDA-10CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD+PPX with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10X
Not in Commercial Distribution

  • 00858998006494 ()
PSDA-10X

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+MTD+PPX+THC with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10PPX
Not in Commercial Distribution

  • 00858998006456 ()
PSDA-10PPX

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10MO
Not in Commercial Distribution

  • 00858998006449 ()
PSDA-10MO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(OXY/MDMA)+AMP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10MMO300
Not in Commercial Distribution

  • 00858998006432 ()
PSDA-10MMO300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+BUP+MTD with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSDA-10BUP
Not in Commercial Distribution

  • 00858998006425 ()
PSDA-10BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSCupA-7MOB
Not in Commercial Distribution

  • 00858998006173 ()
USSCupA-7MOB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants 7 Panel Drug Screen (CR,SG,OX) for (THC/COC/OPI2000/AMP/MET/PCP/BZO)
Instant Tech Subsidiary Acquisition
USSCupA-7BP CM
Not in Commercial Distribution

  • 00858998006166 ()
USSCupA-7BP CM

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY with adulteration OX/SG/pH drugs of abuse test cup
NEXSCREEN, LLC
61101Y-3A
In Commercial Distribution

  • 00858984006156 ()
61101Y-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, TCA, OXY with adulteration OX/SG/pH drugs of abuse test cup
NEXSCREEN, LLC
61107N-3A
Not in Commercial Distribution

  • 00858984006064 ()
61107N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY with adulteration OX/SG/pH drugs of abuse test cup
NEXSCREEN, LLC
61101N-3A
In Commercial Distribution

  • 00858984006057 ()
61101N-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Cup for (COC/THC)+(PCP/AMP)+BZO+OPI+OXY with Cr, Ni, pH, Bl, S.G. (CLIA Waived)
NOBLE MEDICAL INC
NBCA-7C-W
In Commercial Distribution

  • 00858886006308 ()
NBCA-7C-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/MTD/OPI/THC
HEMOSURE INC.
FSCECOII-4854
In Commercial Distribution

  • 00857338006897 ()
  • 00857338006903 ()
FSCECOII-4854

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/mAMP/MOR/THC
HEMOSURE INC.
FSCECOII-2974
In Commercial Distribution

  • 00857338006798 ()
  • 00857338006804 ()
FSCECOII-2974

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/OXY/THC
HEMOSURE INC.
FSCECOII-174
In Commercial Distribution

  • 00857338006668 ()
  • 00857338006743 ()
FSCECOII-174

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCECOII-874
In Commercial Distribution

  • 00857338006651 ()
  • 00857338006750 ()
FSCECOII-874

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (100 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007581 ()
  • 30855944007582 ()
ACDOA-6125B-100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (50 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007574 ()
  • 30855944007575 ()
ACDOA-6125B-50

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (10 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 00855944007567 ()
  • 30855944007568 ()
ACDOA-6125B-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (25 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007298 ()
  • 00855944007291 ()
  • 30855944007292 ()
ACDOA-6125B-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 12 Panel Drug Test Cup (5 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
EASY HEALTHCARE CORPORATION
ACDOA-6125B
In Commercial Distribution

  • 10855944007281 ()
  • 00855944007284 ()
  • 30855944007285 ()
ACDOA-6125B-5

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