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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5 InCup/Thc,coc,amp,bzo,opi300
AMERICAN BIO MEDICA CORPORATION
10-5ZC-030
In Commercial Distribution

  • 10694644400363 ()
  • 10694644450368 ()
10-5ZC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5InCup w/Amp/Bzo/meth/opi3/thc
AMERICAN BIO MEDICA CORPORATION
10-5SPC-382.5
In Commercial Distribution

  • 10694644400332 ()
  • 10694644450337 ()
10-5SPC-382.5

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 InCp/Amp, Bzo,opi3,THC,MDMA
AMERICAN BIO MEDICA CORPORATION
10-5SPC-334
In Commercial Distribution

  • 10694644400325 ()
  • 10694644450320 ()
10-5SPC-334

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 InCup/Thc,coc,meth,oxy,opi3
AMERICAN BIO MEDICA CORPORATION
10-5OC-030
In Commercial Distribution

  • 10694644400288 ()
  • 10694644450283 ()
10-5OC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 InCup w/Coc, OXY,THC, Opi3
AMERICAN BIO MEDICA CORPORATION
10-4OC-030
In Commercial Distribution

  • 10694644400233 ()
  • 10694644450238 ()
10-4OC-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 Pan InCup/Thc,Coc,Meth +SVT
AMERICAN BIO MEDICA CORPORATION
10-3MCA-000
In Commercial Distribution

  • 10694644400172 ()
  • 10694644450177 ()
10-3MCA-000

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

  • 10694644400165 ()
  • 10694644450160 ()
10-3MC-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RDS KIT AMP/BAR/COC/OPI2K/THC
AMERICAN BIO MEDICA CORPORATION
10-5SPA6-141
In Commercial Distribution

  • 10694644300397 ()
  • 10694644350392 ()
10-5SPA6-141

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4w/Thc,Coc,Amp,Meth BULK 50
AMERICAN BIO MEDICA CORPORATION
10-4SPB-181
In Commercial Distribution

  • 10694644300250 ()
  • 10694644350255 ()
10-4SPB-181

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4 RDS/Bzo,Coc,Thc,opi3 CARD
AMERICAN BIO MEDICA CORPORATION
10-4BS-030
In Commercial Distribution

  • 10694644300212 ()
  • 10694644350217 ()
10-4BS-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
4RDS w/Bzo,coc,opi3,Thc single
AMERICAN BIO MEDICA CORPORATION
10-4B1-030
In Commercial Distribution

  • 10694644300205 ()
  • 10694644350200 ()
10-4B1-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3Pw/THC,Coc,Meth(single) 25/BO
AMERICAN BIO MEDICA CORPORATION
10-3M1-000
In Commercial Distribution

  • 10694644300113 ()
  • 10694644350118 ()
10-3M1-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 panel w/Thc&Coc BULK PACK
AMERICAN BIO MEDICA CORPORATION
10-2CS-000
In Commercial Distribution

  • 10694644300106 ()
  • 10694644350101 ()
10-2CS-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
2 Panel w/THC&CocSingle 25/BOX
AMERICAN BIO MEDICA CORPORATION
10-2C1-000
In Commercial Distribution

  • 10694644300076 ()
  • 10694644350071 ()
10-2C1-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RapidTox THC/COC/METH/OPI300/AMP/BZO
AMERICAN BIO MEDICA CORPORATION
10-6MZT-030
In Commercial Distribution

  • 10694644100447 ()
  • 10694644150442 ()
10-6MZT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RAPIDTOX WITH 3 PAD SVT, THC/M
AMERICAN BIO MEDICA CORPORATION
10-6STA3-200
In Commercial Distribution

  • 10694644100195 ()
  • 10694644150190 ()
10-6STA3-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 pan Rapid Tox/Thc,coc,amp
AMERICAN BIO MEDICA CORPORATION
10-3XT-000
In Commercial Distribution

  • 10694644100096 ()
  • 10694644150091 ()
10-3XT-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Rapid TOX 3 pan/Thc,Coc,opi300
AMERICAN BIO MEDICA CORPORATION
10-3OT-030
In Commercial Distribution

  • 10694644100089 ()
  • 10694644150084 ()
10-3OT-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 pan Rapid TOX/thc, coc, meth
AMERICAN BIO MEDICA CORPORATION
10-3MT-000
In Commercial Distribution

  • 10694644100072 ()
  • 10694644150077 ()
10-3MT-000

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RAPIDTOX WITH 3 PAD SVT/THC/C
AMERICAN BIO MEDICA CORPORATION
10-10XTA3-030
In Commercial Distribution

  • 10694644100058 ()
  • 10694644150053 ()
10-10XTA3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
THC One Step Marijuana Test Device (THC50)
ALERE SAN DIEGO, INC.
DTH-102
In Commercial Distribution

  • 10815845020307 ()
  • 00815845020300 ()
4012380099

  • 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
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
Syva® RapidTest d.a.u.® Cannabinoids THC
Siemens Healthcare Diagnostics Inc.
10445347
In Commercial Distribution

  • 00842768001192 ()
  • 00630414013800 ()
6A029UL

  • Cannabinoid/cannabinoid metabolite 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
AMP500/BZO300/COC150/MET500/OPI2000/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD07071 ()
  • B115ABCARD07070 ()
ABCard-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

  • B115ABCARD07061 ()
  • B115ABCARD07060 ()
ABCard-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

  • B115ABCARD07041 ()
  • B115ABCARD07040 ()
ABCard-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

  • B115ABCARD07031 ()
  • B115ABCARD07030 ()
ABCard-07-03

  • 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
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