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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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Advin Multi-Drug Screen Test - B115ABCARD06041

AMP/COC/MET/MOR/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD06041 ()
  • B115ABCARD06040 ()
ABCard-06-04

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

Advin Multi-Drug Screen Test - B115ABCARD06011

AMP/BZO/COC/MET/MOR/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD06011 ()
  • B115ABCARD06010 ()
ABCard-06-01

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

PETROLATUM GAUZE® - 10381780491750

Petrolatum Gauze Non-Adhering Dressing
Derma Sciences Canada Inc
20065
In Commercial Distribution

  • 30381780491754 ()
  • 10381780491750 ()

  • 15.2 com X 91.4 cm
  • 6 in X 36 in
DKC20065

  • Petrolatum woven gauze pad

Surgical Direct - B382SD15718250

5mm 32cm Hunter Bowel Grasper, Fenestrated, 22mm Jaw, With Non-Locking, Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD15718-25
In Commercial Distribution

  • B382SD15718250 ()
SD15718-25

  • Flexible endoscopic tissue manipulation forceps, single-use

Surgical Direct - B382SD13238130

5mm 45cm Atraumatic, Endo-Clinch Grasper, Wtih On/Off Style Ratchet Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD13238-13
In Commercial Distribution

  • B382SD13238130 ()
SD13238-13

  • Flexible endoscopic tissue manipulation forceps, single-use

Surgical Direct - B382SD13128250

5mm 32cm Johan Grasper, 22mm Single Action Jaws, Rotating, Non-Locking, Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD13128-25
In Commercial Distribution

  • B382SD13128250 ()
SD13128-25

  • Flexible endoscopic tissue manipulation forceps, single-use

Surgical Direct - B382SD13818210

5mm 36cm Atraumatic, Long Jaw, Wave Grasper, Single Action Non-Locking, Reinforced, Carbon Fiber Com
Surgical Direct, Inc.
SD13818-21
In Commercial Distribution

  • B382SD13818210 ()
SD13818-21

  • Flexible endoscopic tissue manipulation forceps, single-use

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

DrugConfirm - 00856464008416

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

  • 00856464008416 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent

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

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

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

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

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
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