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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THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-61203N
In Commercial Distribution

  • 00858984006149 ()
C-61203N

  • 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/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
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 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
DrugSmart Cup 10, AMP/BAR/BZO/COC/MDMA/MET/OPI2K/PCP/TCA/THC + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
61060D-6AB
In Commercial Distribution

  • 00812203030780 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 10, AMP/COC/THC/OPI2000/MET/PCP/BAR/BZO/MTD/OXY + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
61020D-6AB
In Commercial Distribution

  • 00812203030612 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Ox/pH/SG) - PB
CHEMTRON BIOTECH INC
PCA-12PXS-ALT
In Commercial Distribution

  • 00812203030490 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-panel DOA Cup AMP500/BAR/BZO/COC150/MDMA/MET500/MTD/OPI300/OXY/PCP/PPX/THC (Cr/Ox/pH) - PB
CHEMTRON BIOTECH INC
PCA-12PXS-LC
In Commercial Distribution

  • 00812203030353 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP/BAR/BUP/BZO/COC/MET/MTD/OPI2000/OXY/PCP/PPX/TCA/THC - 25 tests/kit
CHEMTRON BIOTECH INC
712M06
In Commercial Distribution

  • 00812203030056 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel DOA Cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25tests/kit
CHEMTRON BIOTECH INC
712G03A
In Commercial Distribution

  • 00812203030025 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-7P
Not in Commercial Distribution

  • 00816565020250 ()
IMCA-7P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/BZO/COC/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests (CLIA Waived)
AMEDITECH INC.
IMCA-5AB-W
Not in Commercial Distribution

  • 00816565020205 ()
IMCA-5AB-W

  • 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
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
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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