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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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CLIAwaived,Inc. One Step Drug Test Cup-7 panel configuration (THC,COC,OPI 300,mAMP,MTD,OXY, BZO) -(25T/KIT)
Cliawaived, Inc.
CLIA-IDTC-7-60717
In Commercial Distribution

  • 00816610020921 ()
CLIA-IDTC-7-60717

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

USSCup-10M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCupA-5M
In Commercial Distribution

USSCupA-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
T-Cup® Compact Multi-Drug Urine Test Cup <AMP, BAR, BZO, COC, MDMA, MET, MOP, MTD, OXY, PCP, TCA, THC>
Instant Technologies, Inc.
ACDOA-7125
In Commercial Distribution

  • 00817405021017 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+MDMA+MET1000+OPI300+OXY with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSDA-8MBO300
Not in Commercial Distribution

  • 00817405020836 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC with CR/pH/S.G.
WONDFO USA CO., LTD.
CDOA-6124A3
In Commercial Distribution

  • 10816862026495 ()
  • 00816862026498 ()
  • 00816862026481 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,PPX,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-1145A3
In Commercial Distribution

  • 00816862025071 ()
TDOA-1145A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-1144A3
In Commercial Distribution

  • 00816862025064 ()
TDOA-1144A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup 5 per Box; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
WONDFO USA CO., LTD.
DTDOA-1144-5BX-A
In Commercial Distribution

  • 10816862023944 ()
  • 00816862023947 ()
  • 00816862023954 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC with 3 AD
WONDFO USA CO., LTD.
DTDOA-1144A3-5BX-A
In Commercial Distribution

  • 10816862022107 ()
  • 00816862022100 ()
  • 00816862022117 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Preview Cup 3AD; AMP,BAR,BUP,BZO,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC+CR,SG,pH
WONDFO USA CO., LTD.
PRE-PDOA-6124A3
In Commercial Distribution

  • 10816862020981 ()
  • 00816862020984 ()
  • 00816862029987 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC with 3 AD & Vacu Lid
WONDFO USA CO., LTD.
TDOA-6125A3V
In Commercial Distribution

  • 10816862020974 ()
  • 00816862020977 ()
  • 00816862029970 ()
TDOA-6125A3V

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,PPX,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-1145A3
In Commercial Distribution

  • 10816862020073 ()
  • 00816862020076 ()
  • 00816862029079 ()
TDOA-1145A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-1144A3
In Commercial Distribution

  • 10816862020066 ()
  • 00816862020069 ()
  • 00816862029062 ()
TDOA-1144A3

  • 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
Identify® Diagnostics-Home Drug Testing Device Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850721007420 ()
  • 10850721007423 ()
  • 00850721007426 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify ® -Home Drug Testing Device Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC"
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850721007413 ()
  • 10850721007416 ()
  • 00850721007419 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen 11 Panel Test Card THC/COC/OPI/AMP/BZO/BAR/MET/OXY/MTD/BUP/TCA)
UCP BIOSCIENCES, INC.
UDO-6123
In Commercial Distribution

  • 20817038021907 ()
  • 10817038021900 ()
  • 00817038021903 ()
UDO-6123

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Cup Drug Test Screen 10 Panel Drug Test Cup (BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC)
UCP BIOSCIENCES, INC.
U-CUP-7104
In Commercial Distribution

  • 20817038021860 ()
  • 10817038021863 ()
  • 00817038021866 ()
U-CUP-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-12-1ML
In Commercial Distribution

  • 20817038021754 ()
  • 10817038021757 ()
  • 00817038021750 ()
UCC-12-1ML

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-12-1M
In Commercial Distribution

  • 20817038021747 ()
  • 10817038021740 ()
  • 00817038021743 ()
UCC-12-1M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/BUP/TCA/THC
UCP BIOSCIENCES, INC.
U-CUP-8134-RCN
In Commercial Distribution

  • 20817038020641 ()
  • 10817038020644 ()
  • 00817038020647 ()
U-CUP-8134-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived BZO/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCCUP-654
In Commercial Distribution

  • 00817763020523 ()
  • 00817763021193 ()
FSCCUP-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCCUP-254
In Commercial Distribution

  • 00817763020509 ()
  • 00817763021179 ()
FSCCUP-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-AMP / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7206-12
In Commercial Distribution

  • M90107RD7206120 ()

  • Length: 74 Millimeter
07RD7206-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7206-11
In Commercial Distribution

  • M90107RD7206110 ()

  • Length: 74 Millimeter
07RD7206-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI-2000 / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7206-09
In Commercial Distribution

  • M90107RD7206090 ()

  • Length: 74 Millimeter
07RD7206-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7206-05
In Commercial Distribution

  • M90107RD7206050 ()

  • Length: 74 Millimeter
07RD7206-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7206-01
In Commercial Distribution

  • M90107RD7206010 ()

  • Length: 74 Millimeter
07RD7206-01

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