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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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T-Cup - 00816862020083

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

INCUP - 10694644400417

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

INCUP - 10694644400363

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

INCUP - 10694644400332

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

INCUP - 10694644400325

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

INCUP - 10694644400288

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

INCUP - 10694644400233

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

INCUP - 10694644400172

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

INCUP - 10694644400165

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 - 10694644300397

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

RDS - 10694644300250

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

RDS - 10694644300212

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

RDS - 10694644300205

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

RDS - 10694644300113

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

RDS - 10694644300106

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

RDS - 10694644300076

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

Rapid TOX - 10694644100447

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

Rapid TOX - 10694644100195

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

Rapid TOX - 10694644100096

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 - 10694644100089

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

Rapid TOX - 10694644100072

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

Rapid TOX - 10694644100058

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

Rite Aid - 00011822001687

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

RTCII 2nd gen. - 10694644500308

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 2nd gen. - 10694644500223

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 2nd gen. - 10694644500216

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

ReliOn 1 Panel Home Drug Test Kit - 00895330002356

1 Panel Home Drug Test Kit THC
CONFIRM BIOSCIENCES, INC.
RO-DRC001
In Commercial Distribution

  • 00895330002356 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Immunalysis - 00840937109380

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

Immunalysis - 00840937109373

THC Enzyme Conjugate Analyte Specific Reagent (ASR)
IMMUNALYSIS CORP
ASR-E-324-60
In Commercial Distribution

  • 00840937109373 ()


  • Assay development analyte-specific reagent IVD

NA - 10815845020307

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

PreKnow - 00857275007506

Marijuana THC Single Drug Test Dip Card
IDUN SOLUTIONS LLC
21115061010308
In Commercial Distribution

  • 00857275007506 ()
  • 00857275007384 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

DrugSmart Dip - 00859144006313

(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

DrugSmart Dip - 00859144006245

(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 - 00850019007435

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.® THC - 00842768001192

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

DrugConfirm - 00856464008416

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

  • 00856464008416 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent

OralTox - B313OT804011

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 - B29880140EI0

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

Areta MarijuanaTest Strip -THC(15 tests kit) - 00810038634081

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

Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (20 tests/kit) - 00810038632018

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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