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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6-Panel Card; AMP,COC,mAMP,OPI,PCP,THC
WONDFO USA CO., LTD.
WDOA-164
In Commercial Distribution

  • 10816862020547 ()
  • 00816862020540 ()
  • 00816862029543 ()
WDOA-164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup; BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
TDOA-564
In Commercial Distribution

  • 10816862020226 ()
  • 00816862020229 ()
  • 00816862029222 ()
TDOA-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
TDOA-264
In Commercial Distribution

  • 10816862020141 ()
  • 00816862020144 ()
  • 00816862029147 ()
TDOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup; AMP,COC,MET,OPI,PCP,THC
WONDFO USA CO., LTD.
TDOA-164
In Commercial Distribution

  • 10816862020097 ()
  • 00816862020090 ()
  • 00816862029093 ()
TDOA-164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Key Cup; AMP,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
KDOA-254
In Commercial Distribution

  • 10816862020004 ()
  • 00816862020007 ()
  • 00816862029000 ()
KDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80510
Not in Commercial Distribution

  • B313OT805101 ()
  • B313OT805100 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - AMP/COC/MET/OPI/THC
PREMIER BIOTECH, INC
OT80508
Not in Commercial Distribution

  • B313OT805081 ()
  • B313OT805080 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - AMP/COC/OPI/PCP/THC
PREMIER BIOTECH, INC
OT80504
Not in Commercial Distribution

  • B313OT805041 ()
  • B313OT805040 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox - AMP/COC/MET/OPI/THC
PREMIER BIOTECH, INC
OT80502
Not in Commercial Distribution

  • B313OT805021 ()
  • B313OT805020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Card; BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
WDOA-564
In Commercial Distribution

  • 00816862025668 ()
WDOA-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Card; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
WDOA-264
In Commercial Distribution

  • 00816862025576 ()
WDOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Card; AMP,COC,mAMP,OPI,PCP,THC
WONDFO USA CO., LTD.
WDOA-164
In Commercial Distribution

  • 00816862025545 ()
WDOA-164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup; AMP,COC,MET,OPI,PCP,THC
WONDFO USA CO., LTD.
TDOA-164
In Commercial Distribution

  • 00816862025095 ()
TDOA-164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Preview Cup; AMP,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
PRE-PDOA-254
In Commercial Distribution

  • 10816862021421 ()
  • 00816862021424 ()
  • 00816862028423 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Card; BZO,COC,mAMP,MOP,OXY,THC
WONDFO USA CO., LTD.
WDOA-565
In Commercial Distribution

  • 00816862025675 ()
WDOA-565

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup; BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
TDOA-564
In Commercial Distribution

  • 00816862025224 ()
TDOA-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
TDOA-264
In Commercial Distribution

  • 00816862025149 ()
TDOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Key Cup; AMP,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
KDOA-254
In Commercial Distribution

  • 00816862025002 ()
KDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4-Panel T-Square no THC; COC,MET,OPI,PCP
WONDFO USA CO., LTD.
QODOA-046NTEUO
In Commercial Distribution

  • 10816862023500 ()
  • 00816862023503 ()
  • 00816862023510 ()
QODOA-046NTEUO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4-Panel T-Cup without THC; AMP,COC,OPI,PCP
WONDFO USA CO., LTD.
TDOA-744NT
In Commercial Distribution

  • 10816862023494 ()
  • 00816862023497 ()
  • 00816862023718 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Square; AMP, COC, MET, OPI, PCP, THC
WONDFO USA CO., LTD.
QODOA-166EUO
In Commercial Distribution

  • 10816862023067 ()
  • 00816862023060 ()
  • 00816862023077 ()
QODOA-166EUO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cube; AMP,COC,MET,OPI,OXY,THC
WONDFO USA CO., LTD.
ODOA-666EUO
In Commercial Distribution

  • 00816862022377 ()
  • 00816862022353 ()
  • 00816862022360 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Card; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
DWDOA-264-5B-B
In Commercial Distribution

  • 10816862022121 ()
  • 00816862022124 ()
  • 00816862022131 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cube; AMP,COC,MET,OPI,PCP,THC
WONDFO USA CO., LTD.
ODOA-166
In Commercial Distribution

  • 10816862022060 ()
  • 00816862022063 ()
  • 00816862022070 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cube; AMP,BAR,COC,OPI,PCP,THC
WONDFO USA CO., LTD.
ODOA-966EUO
In Commercial Distribution

  • 00816862022001 ()
  • 00816862022018 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup Compact; AMP,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
CDOA-254
In Commercial Distribution

  • 10816862021209 ()
  • 00816862021202 ()
  • 00816862028201 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
SYNCHRON Systems 20 ng/mL THC Urine Calibrator
Beckman Coulter, Inc.
464390
In Commercial Distribution

  • 15099590231644 ()
464390

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
SYNCHRON Systems 50 ng/mL THC Urine Calibrator
Beckman Coulter, Inc.
445809
In Commercial Distribution

  • 15099590230500 ()
445809

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
Cannabinoid 100 ng Reagent (THC 1 x 150)
Beckman Coulter, Inc.
445990
In Commercial Distribution

  • 15099590229801 ()
445990

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
SYNCHRON Systems 100 ng/mL THC Urine Calibrator
Beckman Coulter, Inc.
445811
In Commercial Distribution

  • 15099590229559 ()
445811

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
SYNCHRON Systems 125 ng/mL THC Urine Control
Beckman Coulter, Inc.
465939
In Commercial Distribution

  • 15099590228743 ()
465939

  • Cannabinoid/cannabinoid metabolite IVD, control
SYNCHRON Systems 75 ng/mL THC Urine Control
Beckman Coulter, Inc.
465912
In Commercial Distribution

  • 15099590227258 ()
465912

  • Cannabinoid/cannabinoid metabolite IVD, control
SYNCHRON Systems 20 ng/mL THC Urine Control
Beckman Coulter, Inc.
465914
In Commercial Distribution

  • 15099590227234 ()
465914

  • Cannabinoid/cannabinoid metabolite IVD, control
SYNCHRON Systems 200 ng/mL THC Urine Calibrator
Beckman Coulter, Inc.
445814
In Commercial Distribution

  • 15099590224868 ()
445814

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
SYNCHRON Systems 10 ng/mL THC Urine Control
Beckman Coulter, Inc.
472107
In Commercial Distribution

  • 15099590223434 ()
472107

  • Cannabinoid/cannabinoid metabolite IVD, control
SYNCHRON Systems 40 ng/mL THC Urine Control
Beckman Coulter, Inc.
472110
In Commercial Distribution

  • 15099590223427 ()
472110

  • Cannabinoid/cannabinoid metabolite IVD, control
5 tests kit;Marijuana Test Strip(THC 20)
EASY HEALTHCARE CORPORATION
ESTH-215
In Commercial Distribution

  • 10810038638093 ()
  • 00810038638096 ()
  • 20810038638090 ()
ESTH-215-5

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Rapid Response Multi Drug Test Panels (COC/THC) are for the qualitative detection of Cocaine and THC metabolites in urine.
BTNX Inc
D2.1-1P29-25
In Commercial Distribution

  • 00722066000762 ()
  • 00722066003947 ()
D2.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Single Drug Test Cassette (THC) - 40 tests/ kit are for the qualitative detection of THC metabolite in urine.
BTNX Inc
THC-1C13-40
In Commercial Distribution

  • 00722066000731 ()
  • 00722066003886 ()
THC-1C13-40

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