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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PANEL 06 COC150/THC/MOP300/OXY100/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020202
In Commercial Distribution

  • 10858904006621 ()
  • 00858904006624 ()
DOA-164-1541

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 05 COC150/AMP1000/MAMP500/THC/MOP300
REDWOOD TOXICOLOGY LABORATORY, INC.
011020201
In Commercial Distribution

  • 10858904006614 ()
  • 00858904006617 ()
DOA-154-1811

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 05 COC150/THC/MOP300/MAMP500/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020200
In Commercial Distribution

  • 10858904006607 ()
  • 00858904006600 ()
DOA-154-1801

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 05 COC150/MAMP500/THC/OPI/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020196
In Commercial Distribution

  • 10858904006591 ()
  • 00858904006594 ()
DOA-154-1791

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/AMP/THC/OPI2/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020047
In Commercial Distribution

  • 10858904006287 ()
  • 00858904006280 ()
DOA-154-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/AMP/THC/OPI/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020033
In Commercial Distribution

  • 10858904006270 ()
  • 00858904006273 ()
DOA-1154-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/M-AMP/THC/OPI/PCP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020013
In Commercial Distribution

  • 10858904006263 ()
  • 00858904006266 ()
DOA-554-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/AMP/M-AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020034
In Commercial Distribution

  • 10858904006256 ()
  • 00858904006259 ()
DOA-454-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 5 COC/M-AMP/THC/OPI/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020015
In Commercial Distribution

  • 10858904006249 ()
  • 00858904006242 ()
DOA-654-OBC12B

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC Enzyme Conjugate Analyte Specific Reagent (ASR)
IMMUNALYSIS CORP
ASR-E-324-600
In Commercial Distribution

  • 00840937109380 ()
ASR-E-324-600

  • Assay development analyte-specific reagent IVD
THC Enzyme Conjugate Analyte Specific Reagent (ASR)
IMMUNALYSIS CORP
ASR-E-324-60
In Commercial Distribution

  • 00840937109373 ()


  • Assay development analyte-specific reagent IVD
INSTANT-VIEW Marijuana (THC) Urine Dip Cassette Test
ALFA SCIENTIFIC DESIGNS, INC.
03-3072QW
In Commercial Distribution

  • 10796918000467 ()
  • 00796918000460 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
5-Panel Card; AMP,BZO,COC,OPI,THC
WONDFO USA CO., LTD.
WDOA-754
In Commercial Distribution

  • 00816862025743 ()
WDOA-754

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
WDOA-654
In Commercial Distribution

  • 00816862025705 ()
WDOA-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; COC,mAMP,MDMA,OPI,THC
WONDFO USA CO., LTD.
WDOA-554
In Commercial Distribution

  • 00816862025651 ()
WDOA-554

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
WDOA-354
In Commercial Distribution

  • 00816862025620 ()
WDOA-354

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; AMP,COC,OPI,PCP,THC
WONDFO USA CO., LTD.
WDOA-154
In Commercial Distribution

  • 00816862025538 ()
WDOA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; AMP,COC,OPI,PCP,THC
WONDFO USA CO., LTD.
TDOA-154
In Commercial Distribution

  • 00816862025088 ()
TDOA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cube; AMP,COC,MET,OPI,THC
WONDFO USA CO., LTD.
DODOA-256-EUO-25BX-B
In Commercial Distribution

  • 10816862022190 ()
  • 00816862022193 ()
  • 00816862022209 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; AMP,BUP,COC,MOP,THC
WONDFO USA CO., LTD.
TDOA-955
In Commercial Distribution

  • 10816862020936 ()
  • 00816862020939 ()
  • 00816862029932 ()
TDOA-955

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; BZO,COC,mAMP,MOP,THC
WONDFO USA CO., LTD.
WDOA-655
In Commercial Distribution

  • 10816862020714 ()
  • 00816862020717 ()
  • 00816862029710 ()
WDOA-655

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

  • 10816862020561 ()
  • 00816862020564 ()
  • 00816862029567 ()
WDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; AMP,COC,OPI,PCP,THC
WONDFO USA CO., LTD.
TDOA-154
In Commercial Distribution

  • 10816862020080 ()
  • 00816862020083 ()
  • 00816862029086 ()
TDOA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel OralTox - AMP/COC/OPI/THC
PREMIER BIOTECH, INC
OT80401
Not in Commercial Distribution

  • B313OT804011 ()
  • B313OT804010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugCheck SalivaScan Oral Fluid Drug Test - THC
Express Diagnostic Int'l, Inc.
80140-EI
In Commercial Distribution

  • B29880140EI0 ()
80140-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 tests per kit;THC Single Panel
EASY HEALTHCARE CORPORATION
ASTH-114C
In Commercial Distribution

  • 10810038634088 ()
  • 00810038634081 ()
  • 30810038634082 ()
ASTH-114-15C15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
20 tests per kit;THC Single Panel
EASY HEALTHCARE CORPORATION
EDTH-114
In Commercial Distribution

  • 10810038632015 ()
  • 00810038632018 ()
  • 30810038632019 ()
EDTH-114-20

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
5 tests per kit;THC Single Panel
EASY HEALTHCARE CORPORATION
EDTH-114
In Commercial Distribution

  • 10810038631636 ()
  • 00810038631639 ()
  • 30810038631630 ()
EDTH-114-5

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
5-Panel Card; BZO,COC,mAMP,MOP,THC
WONDFO USA CO., LTD.
WDOA-655
In Commercial Distribution

  • 00816862025712 ()
WDOA-655

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

  • 00816862025569 ()
WDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
TDOA-654
In Commercial Distribution

  • 00816862025279 ()
TDOA-654

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

  • 00816862025125 ()
TDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cube; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
ODOA-256EUO
In Commercial Distribution

  • 10816862022831 ()
  • 00816862022834 ()
  • 00816862022841 ()
ODOA-256EUO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel Preview Dip Card; COC,mAMP,THC
WONDFO USA CO., LTD.
PRE-WDOA-232
In Commercial Distribution

  • 00816862022506 ()
  • 00816862022483 ()
  • 00816862022490 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; AMP,BZO,COC,OPI,THC
WONDFO USA CO., LTD.
WDOA-754
In Commercial Distribution

  • 10816862020745 ()
  • 00816862020748 ()
  • 00816862029741 ()
WDOA-754

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
WDOA-654
In Commercial Distribution

  • 10816862020707 ()
  • 00816862020700 ()
  • 00816862029703 ()
WDOA-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; COC,mAMP,MDMA,OPI,THC
WONDFO USA CO., LTD.
WDOA-554
In Commercial Distribution

  • 10816862020653 ()
  • 00816862020656 ()
  • 00816862029659 ()
WDOA-554

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
WDOA-354
In Commercial Distribution

  • 10816862020622 ()
  • 00816862020625 ()
  • 00816862029628 ()
WDOA-354

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; AMP,COC,OPI,PCP,THC
WONDFO USA CO., LTD.
WDOA-154
In Commercial Distribution

  • 10816862020530 ()
  • 00816862020533 ()
  • 00816862029536 ()
WDOA-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
TDOA-654
In Commercial Distribution

  • 10816862020271 ()
  • 00816862020274 ()
  • 00816862029277 ()
TDOA-654

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

  • 10816862020127 ()
  • 00816862020120 ()
  • 00816862029123 ()
TDOA-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3 panel test cup, COC/OPI2000/THC
AMEDITECH INC.
IMC-3P
Not in Commercial Distribution

  • 00816565020120 ()
IMC-3P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP10/BZO300/COC150/MOR300/OPI2000/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP07141 ()
  • B115ABCUP07140 ()
ABCup-07-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/COC150/MET500/MOR300/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP07091 ()
  • B115ABCUP07090 ()
ABCup-07-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP07071 ()
  • B115ABCUP07070 ()
ABCup-07-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP07061 ()
  • B115ABCUP07060 ()
ABCup-07-06

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

  • B115ABCUP07041 ()
  • B115ABCUP07040 ()
ABCup-07-04

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

  • B115ABCUP07031 ()
  • B115ABCUP07030 ()
ABCup-07-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP10/BZO300/COC150/MOR300/OPI2000/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD07141 ()
  • B115ABCARD07140 ()
ABCard-07-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/COC150/MET500/MOR300/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD07091 ()
  • B115ABCARD07090 ()
ABCard-07-09

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