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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Chemtrue® THC Dip Card Test, 25pcs/kit
CHEMTRON BIOTECH INC
711A06CT
In Commercial Distribution

  • 00850019007206 ()
711A06CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
Incup with AMP/COC/OPI300/OXY/THC/SVT
AMERICAN BIO MEDICA CORPORATION
10-5SPCA-386
In Commercial Distribution

  • 10694644450740 ()
  • 10694644400745 ()
10-5SPCA-386

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 Pan InCup/Amp,OPI 300,THC +SVT
AMERICAN BIO MEDICA CORPORATION
10-3ACA-030
In Commercial Distribution

  • 10694644400660 ()
  • 10694644450665 ()
10-3ACA-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 InCup/Bzo,coc,op3, thc 25/cs
AMERICAN BIO MEDICA CORPORATION
10-4BC-030
In Commercial Distribution

  • 10694644400196 ()
  • 10694644450191 ()
10-4BC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 Pan InCup/Thc,coc,amp,opi 3
AMERICAN BIO MEDICA CORPORATION
10-4AC-030
In Commercial Distribution

  • 10694644400189 ()
  • 10694644450184 ()
10-4AC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 Pan InCup/Thc,coc,opi 300 ng
AMERICAN BIO MEDICA CORPORATION
10-3OC-030
In Commercial Distribution

  • 10694644400158 ()
  • 10694644450153 ()
10-3OC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
6/coc,amp,meth,thc,bzo,opi3 BP
AMERICAN BIO MEDICA CORPORATION
10-6SPB-152
In Commercial Distribution

  • 10694644300489 ()
  • 10694644350484 ()
10-6SPB-152

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
6/coc,amp,meth,thc,bzo,opi3 si
AMERICAN BIO MEDICA CORPORATION
10-6SP-152
In Commercial Distribution

  • 10694644300472 ()
  • 10694644350477 ()
10-6SP-152

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 RDS/COC,OXY,THC,Op3 CARD 50
AMERICAN BIO MEDICA CORPORATION
10-4OS-030
In Commercial Distribution

  • 10694644300243 ()
  • 10694644350248 ()
10-4OS-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 Pw/Thc,Coc,Meth,Opi 3 single
AMERICAN BIO MEDICA CORPORATION
10-4M1-030
In Commercial Distribution

  • 10694644300229 ()
  • 10694644350224 ()
10-4M1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
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
PANEL 06 COC150/AMP1000/MAMP500/THC/MOP300/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020203
In Commercial Distribution

  • 10858904006638 ()
  • 00858904006631 ()
DOA-164-1551

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 6 COC/M-AMP/THC/MTD/OPI/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020017
In Commercial Distribution

  • 10858904006508 ()
  • 00858904006501 ()
DOA-864-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 6 COC/M-AMP/THC/OPI/BAR/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020024
In Commercial Distribution

  • 10858904006492 ()
  • 00858904006495 ()
DOA-964-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 6 COC/M-AMP/THC/OPI/PCP/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020016
In Commercial Distribution

  • 10858904006485 ()
  • 00858904006488 ()
DOA-764-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 06 COC150/BZO/MAMP500/OPI300/MDMA/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020175
In Commercial Distribution

  • 10858904006331 ()
  • 00858904006334 ()
DOA-164-1491

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 06 COC150/AMP300/MAMP500/OPI300/MDMA/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020174
In Commercial Distribution

  • 10858904006324 ()
  • 00858904006327 ()
DOA-164-1481

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 6 COC/M-AMP/THC/OPI/OXY/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020119
In Commercial Distribution

  • 10858904006317 ()
  • 00858904006310 ()
DOA-164-341

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test MET, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3226
In Commercial Distribution

  • 10796918001976 ()
  • 00796918001979 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3270-20
In Commercial Distribution

  • 10796918000689 ()
  • 00796918000682 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3270
In Commercial Distribution

  • 10796918000672 ()
  • 00796918000675 ()


  • 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,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
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
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,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,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
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
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