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 / 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
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7065-40
In Commercial Distribution

  • 00817830022788 ()

  • Length: 75 Millimeter
07RD-7065-40

  • 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 / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7065-22
In Commercial Distribution

  • 00817830021897 ()

  • Length: 75 Millimeter
07RD7065-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BZD / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7065-17
In Commercial Distribution

  • 00817830021873 ()

  • Length: 75 Millimeter
07RD7065-17

  • 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
RAPID DIAGNOSTICS INC
07RD7065-15
In Commercial Distribution

  • 00817830021859 ()

  • Length: 75 Millimeter
07RD7065-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / COC / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7065-06A
In Commercial Distribution

  • 00817830021804 ()

  • Length: 75 Millimeter
07RD7065-06A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7065-05A
In Commercial Distribution

  • 00817830021781 ()

  • Length: 75 Millimeter
07RD7065-05A

  • 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-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 / BZD / COC / M-AMP / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD-7206-09
In Commercial Distribution

  • 00817830022894 ()

  • Length: 75 Millimeter
07RD-7206-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7065-27
In Commercial Distribution

  • 00817830021941 ()

  • Length: 75 Millimeter
07RD7065-27

  • 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 / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7065-26
In Commercial Distribution

  • 00817830021934 ()

  • Length: 75 Millimeter
07RD7065-26

  • 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 / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7065-25
In Commercial Distribution

  • 00817830021927 ()

  • Length: 75 Millimeter
07RD7065-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BAR / COC / M-AMP / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7065-24
In Commercial Distribution

  • 00817830021910 ()

  • Length: 75 Millimeter
07RD7065-24

  • 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
07RD7065-23
In Commercial Distribution

  • 00817830021903 ()

  • Length: 75 Millimeter
07RD7065-23

  • 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 / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7065-21
In Commercial Distribution

  • 00817830021880 ()

  • Length: 75 Millimeter
07RD7065-21

  • 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-II / THC
RAPID DIAGNOSTICS INC
07RD7065-15A
In Commercial Distribution

  • 00817830021866 ()

  • Length: 75 Millimeter
07RD7065-15A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / COC / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7065-06
In Commercial Distribution

  • 00817830021798 ()

  • Length: 75 Millimeter
07RD7065-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / OPI / THC
RAPID DIAGNOSTICS INC
07RD7065-05
In Commercial Distribution

  • 00817830021774 ()

  • Length: 75 Millimeter
07RD7065-05

  • 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
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
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 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
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
ACCUTEST - 6 Drug Cup (urine strip cup) AMP (1000), COC (300), OPI (2000), MET (1000), THC (50), PCP (25)
JANT PHARMACAL CORPORATION
DS87S625
In Commercial Distribution

  • 10763924087539 ()
  • 00763924087532 ()


  • 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 / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-22
In Commercial Distribution

  • M09107RD7065221 ()
  • M09107RD7065220 ()

  • Length: 75 Millimeter
07RD7065-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Fastep 10 Panel Urine Drug Test Cup (AMP, BUP, BZO, COC, MET, MDMA,MOP,MTD,OXY,THC) – 4 pack
Azure Biotech, Inc.
AZC-8105
In Commercial Distribution

  • 00810022630402 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DUA-167-012 (Ox/SG/pH)+(mAMP/OPI/PCP)+(AMP/COC/THC)MULTI-DRUG 6 PANEL INTEGRATED CUP WITH previous (GTIN 10869419000202)
Quest Diagnostics
UDOA-6CA-0503-01
In Commercial Distribution

  • 00869419000205 ()
  • 20869419000209 ()
DUA-167-012-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BZO/BAR) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Opiates, Oxycodone, Propoxyphene, Phencyclidine, Benzodiazepines, Barbiturate, Cocaine and THC metabolites in urine.
BTNX Inc
D12.8-1P29-25
In Commercial Distribution

  • 00722066003671 ()
  • 00722066004081 ()
D12.8-1P29-25

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