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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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 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
DOA 5 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCCUP-354
In Commercial Distribution

  • 00817763020516 ()
  • 00817763021186 ()
FSCCUP-354

  • 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
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7112-15
In Commercial Distribution

  • M90107RD7112150 ()

  • Length: 74 Millimeter
07RD7112-15

  • 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.
07RD7112-13
In Commercial Distribution

  • M90107RD7112130 ()
  • M90107RD7112131 ()

  • Length: 74 Millimeter
07RD7112-13

  • 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
LUMIQUICK DIAGNOSTICS, INC.
07RD7112-12
In Commercial Distribution

  • M90107RD7112120 ()

  • Length: 74 Millimeter
07RD7112-12

  • 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.
07RD7112-02
In Commercial Distribution

  • M90107RD7112020 ()

  • Length: 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: AMP / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-43
In Commercial Distribution

  • M90107RD7065430 ()
  • M90107RD7065431 ()

  • Length: 75 Millimeter
07RD7065-43

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP/ BZD / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-42
In Commercial Distribution

  • M90107RD7065421 ()
  • M90107RD7065420 ()

  • Length: 75 Millimeter
07RD7065-42

  • 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
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-40
In Commercial Distribution

  • M90107RD7065401 ()
  • M90107RD7065400 ()

  • Length: 75 Millimeter
07RD7065-40

  • 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.
07RD7065-32
In Commercial Distribution

  • M90107RD7065321 ()
  • M90107RD7065320 ()

  • Length: 75 Millimeter
07RD7065-32

  • 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.
07RD7065-31
In Commercial Distribution

  • M90107RD7065311 ()
  • M90107RD7065310 ()

  • Length: 75 Millimeter
07RD7065-31

  • 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
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-28
In Commercial Distribution

  • M90107RD7065281 ()
  • M90107RD7065280 ()

  • Length: 75 Millimeter
07RD7065-28

  • 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
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-23
In Commercial Distribution

  • M90107RD7065231 ()
  • M90107RD7065230 ()

  • 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: BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-15
In Commercial Distribution

  • M90107RD7065151 ()
  • M90107RD7065150 ()

  • 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: BUP / BZD / COC / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-06
In Commercial Distribution

  • M90107RD7065061 ()
  • M90107RD7065060 ()

  • 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 / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-02
In Commercial Distribution

  • M90107RD7065021 ()
  • M90107RD7065020 ()

  • 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 / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-01
In Commercial Distribution

  • M90107RD7065011 ()
  • M90107RD7065010 ()

  • 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 / 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: 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: 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-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
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
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
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
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
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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