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-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
6InCp/Bzo,coc,mtd,op3,oxy,thc
AMERICAN BIO MEDICA CORPORATION
10-6SPC-366
In Commercial Distribution

  • 10694644400417 ()
  • 10694644450412 ()
10-6SPC-366

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
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
Home Drug Test 2 Panel COC/THC
RITE AID CORPORATION
8024509
In Commercial Distribution

  • 00011822001687 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
4 Drug MINICUP THC/COC150/METH500/OPI300
AMERICAN BIO MEDICA CORPORATION
10-4MX3-030
In Commercial Distribution

  • 10694644500308 ()
  • 10694644550303 ()
10-4MX3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII MINI THC/COC150/METH5/MDMA5/FYL-25s
AMERICAN BIO MEDICA CORPORATION
10-9MOX3F-030
Not in Commercial Distribution

  • 10694644500223 ()
  • 10694644550228 ()
10-9MOX3F-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII MINI THC/COC150/METH5/MDMA5/FYL-100s
AMERICAN BIO MEDICA CORPORATION
10-9MOX3FB-030
Not in Commercial Distribution

  • 10694644500216 ()
  • 10694644550211 ()
10-9MOX3FB-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
1 Panel Home Drug Test Kit THC
CONFIRM BIOSCIENCES, INC.
RO-DRC001
In Commercial Distribution

  • 00895330002356 ()


  • Cannabinoid/cannabinoid metabolite 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
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
Marijuana THC Single Drug Test Dip Card
IDUN SOLUTIONS LLC
21115061010308
In Commercial Distribution

  • 00857275007506 ()
  • 00857275007384 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
(BZO/BAR)+AMP+COC+OPI2000+THC DipCard
Twin Spirit Inc.
30640D
Not in Commercial Distribution

  • 00859144006313 ()
30640D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(MET1000/OPI2000)+AMP+BZO+COC+THC DipCard
Twin Spirit Inc.
30600D
Not in Commercial Distribution

  • 00859144006245 ()
30600D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 1 THC CLIA-Waived, 25pcs/kit
CHEMTRON BIOTECH INC
C30140D
In Commercial Distribution

  • 00850019007435 ()
C30140D

  • 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
1 Drug Tested Home Drug Test (THC)
CONFIRM BIOSCIENCES, INC.
CB-DC-1PanelOTC
In Commercial Distribution

  • 00856464008416 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
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
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