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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4 Pw/Thc,coc,Amp,Opi 3 sing
AMERICAN BIO MEDICA CORPORATION
10-4A1-030
In Commercial Distribution

  • 10694644300182 ()
  • 10694644350187 ()
10-4A1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 Pan w/Thc, Coc, Opi 3, sing
AMERICAN BIO MEDICA CORPORATION
10-3O1-000
In Commercial Distribution

  • 10694644300137 ()
  • 10694644350132 ()
10-3O1-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
6RTC2/Bz/Coc/met/ox/thc/op3 SV
AMERICAN BIO MEDICA CORPORATION
10-6ZOX2A-030
In Commercial Distribution

  • 10694644200161 ()
  • 10694644250166 ()
10-6ZOX2A-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
6 RTC2/Bzo/Coc/met/oxy/thc/op3
AMERICAN BIO MEDICA CORPORATION
10-6ZOX2-030
In Commercial Distribution

  • 10694644200154 ()
  • 10694644250159 ()
10-6ZOX2-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTC II WITH THC/COC/OPI/AMP/PC
AMERICAN BIO MEDICA CORPORATION
10-5PX2B-200
In Commercial Distribution

  • 10694644200048 ()
  • 10694644250043 ()
10-5PX2B-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Syva® Emit® II 5B3 THC Assay
Siemens Healthcare Diagnostics Inc.
10445468
Not in Commercial Distribution

  • 00842768023910 ()
9M979UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 5B3 THC Calibrator 50
Siemens Healthcare Diagnostics Inc.
10445466
Not in Commercial Distribution

  • 00842768002151 ()
9M839UL

  • Cannabinoid/cannabinoid metabolite IVD, calibrator
AMP/COC/MET/MOR/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA05021 ()
  • B115ABCUPA05020 ()
ABCupA-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BUP5/BZO300/COC150/MET1000/OPI300/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP08051 ()
  • B115ABCUP08050 ()
ABCup-08-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BUP/BZO/COC/MOR/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP08011 ()
  • B115ABCUP08010 ()
ABCup-08-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/OPI2000/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA05091 ()
  • B115ABCARDA05090 ()
ABCardA-05-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/MOR/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA05071 ()
  • B115ABCARDA05070 ()
ABCardA-05-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
COC/MET/MOR/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA05041 ()
  • B115ABCARDA05040 ()
ABCardA-05-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/MET/MOR/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA05021 ()
  • B115ABCARDA05020 ()
ABCardA-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA05011 ()
  • B115ABCARDA05010 ()
ABCardA-05-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BUP5/BZO300/COC150/MET1000/OPI300/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD08051 ()
  • B115ABCARD08050 ()
ABCard-08-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BUP/BZO/COC/MOR/MTD/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD08011 ()
  • B115ABCARD08010 ()
ABCard-08-01

  • 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

  • 10816862020677 ()
  • 00816862020670 ()
  • 00816862029673 ()
WDOA-565

  • 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

  • 10816862020660 ()
  • 00816862020663 ()
  • 00816862029666 ()
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

  • 10816862020578 ()
  • 00816862020571 ()
  • 00816862029574 ()
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

  • 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
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