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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Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7065-04A
In Commercial Distribution

  • 00817830021767 ()

  • Length: 75 Millimeter
07RD7065-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7065-04
In Commercial Distribution

  • 00817830021750 ()

  • Length: 75 Millimeter
07RD7065-04

  • 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 / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7065-03A
In Commercial Distribution

  • 00817830021743 ()

  • Length: 75 Millimeter
07RD7065-03A

  • 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 / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7065-03
In Commercial Distribution

  • 00817830021736 ()

  • Length: 75 Millimeter
07RD7065-03

  • 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-II/ THC
RAPID DIAGNOSTICS INC
07RD7065-02A
In Commercial Distribution

  • 00817830021729 ()

  • Length: 75 Millimeter
07RD7065-02A

  • 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
RAPID DIAGNOSTICS INC
07RD7065-02
In Commercial Distribution

  • 00817830021712 ()

  • Length: 75 Millimeter
07RD7065-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7065-01A
In Commercial Distribution

  • 00817830021705 ()

  • Length: 75 Millimeter
07RD7065-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7065-01
In Commercial Distribution

  • 00817830021699 ()

  • Length: 75 Millimeter
07RD7065-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / THC
RAPID DIAGNOSTICS INC
07RD7112-09
In Commercial Distribution

  • 00817830020494 ()

  • Height: 74 Millimeter
07RD7112-09

  • 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 / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7112-08
In Commercial Distribution

  • 00817830020487 ()

  • Height: 74 Millimeter
07RD7112-08

  • 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 / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7112-03
In Commercial Distribution

  • 00817830020463 ()

  • Height: 74 Millimeter
07RD7112-03

  • 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
RAPID DIAGNOSTICS INC
07RD7112-02
In Commercial Distribution

  • 00817830020456 ()

  • Height: 74 Millimeter
07RD7112-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7112-01
In Commercial Distribution

  • 00817830020449 ()

  • Height: 74 Millimeter
07RD7112-01

  • 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/MTD/OPI/THC
HEMOSURE INC.
FSCCUP-4854
In Commercial Distribution

  • 00817763020547 ()
  • 00817763021216 ()
FSCCUP-4854

  • 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
DOA 5 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/OPI/PCP/THC
HEMOSURE INC.
FSCCUP-154
In Commercial Distribution

  • 00817763020493 ()
  • 00817763021162 ()
FSCCUP-154

  • 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
STATCUP 7 Panel Test Cup w/Adulterants, AMP/BZO/COC/mAMP/MOR/OXY/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2277-0-A
In Commercial Distribution

  • 00816036027122 ()
  • 00816036026620 ()
SCP-2277-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-2124-0
In Commercial Distribution

  • 00816036025944 ()
  • 00816036026422 ()
SDP-2124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BUP/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-6124-0
In Commercial Distribution

  • 00816036025937 ()
  • 00816036026415 ()
SDP-6124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/PCP/PPX/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-1124-0
In Commercial Distribution

  • 00816036025920 ()
  • 00816036026408 ()
SDP-1124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FASTEST 12 Panel Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
FST-71127-0
In Commercial Distribution

  • 00816036025166 ()
  • 00816036025326 ()
FST-71127-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 8 Panel Test Cup W/AD, AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-2387-0-A
In Commercial Distribution

  • 00816036025074 ()
  • 00816036025234 ()
STATⅡ-2387-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-2167-A
In Commercial Distribution

  • 00816036021311 ()
  • 00816036021496 ()
SCP-2167-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-1257-A
In Commercial Distribution

  • 00816036021281 ()
  • 00816036021465 ()
SCP-1257-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box THC/COC/OPI/mAMP/PCP/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-3257-A
In Commercial Distribution

  • 00816036021267 ()
  • 00816036021441 ()
SCP-3257-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-6157-A
In Commercial Distribution

  • 00816036021243 ()
  • 00816036021427 ()
SCP-6157-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 8 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-184
In Commercial Distribution

  • 00816036020321 ()
  • 00816036020710 ()
SDP-184

  • 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
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
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
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
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