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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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Amazewell - 00850054867605

Amazewell™ Multi-Drug Urine Test Clicker Cup, 6-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
ASUD-264
In Commercial Distribution

  • 30850054867606 ()
  • 00850054867605 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

Amazewell - 00850054867599

Amazewell™ Multi-Drug Urine Test Clicker Cup, 5-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
ASUD-154
In Commercial Distribution

  • 30850054867590 ()
  • 00850054867599 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

NOBLE - 00850054867575

NOBLE Multi-Drug Urine Test Cup, 12-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
NMCup-12-02-DK
In Commercial Distribution

  • 30850054867576 ()
  • 00850054867575 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

Amazewell - 00850054867506

Amazewell™ Multi-Drug Urine Test Clicker Cup, 13-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
ASUD-2135
In Commercial Distribution

  • 30850054867507 ()
  • 00850054867506 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

Amazewell - 00850054867698

Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel
Guangzhou Decheng Biotechnology Co., LTD
AMD-6125
In Commercial Distribution

  • 00850054867698 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

NOBLE - 00850054867674

NOBLE Multi-Drug Urine Test Cup, 13-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
NMCup-13-01-DK
In Commercial Distribution

  • 30850054867675 ()
  • 00850054867674 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

NOBLE - 00850054867667

NOBLE Multi-Drug Urine Test Cup, 9-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
NMCup-09-20-DK
In Commercial Distribution

  • 30850054867668 ()
  • 00850054867667 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

DrugConfirm - 00856464008430

14 Drugs Tested Home Drug Test
CONFIRM BIOSCIENCES, INC.
CB-DC-14PanelOTC
In Commercial Distribution

  • 00856464008430 ()


  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Nortriptyline IVD, reagent
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

Rapid Response - 10722066008260

AMP1000 BAR300 BUP10 BZO300 COC300 MET1000 MDMA500 OPI2000 MTD300 OXY100 PCP25 THC50 PPX300 TCA1000
BTNX Inc
D14.5-1VF
In Commercial Distribution

  • 00722066008263 ()
  • 10722066008260 ()


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

Rapid Response - 10722066007751

AMP1000 BAR300 BUP10 BZO300 COC300 MET1000 MDMA500 OPI2000 MTD300 OXY100 PCP25 THC50 PPX300 TCA1000
BTNX Inc
D14.5-1V
In Commercial Distribution

  • 00722066007754 ()
  • 10722066007751 ()


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

Rapid Response - 10722066007546

12 Panel One Step DOA Cup (12.5) - AMP1000 BAR300 BUP10 BZO300 COC300 MDMA500 MTD300 MET1000 OPI2000 OXY100 THC50 PCP25
BTNX Inc
D12.5-1VF
In Commercial Distribution

  • 00722066007549 ()
  • 10722066007546 ()


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

Healgen (Private Label) - 1145 - 00895330002592

Healgen (DrugConfirm) - 14 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-1145
In Commercial Distribution

  • 00895330002592 ()


  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Nortriptyline IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent

Healgen (Private Label) - 1145 - 00895330002585

Healgen (DrugConfirm) - 14 Panel Dip Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-1145
In Commercial Distribution

  • 00895330002585 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Methadone IVD, reagent
  • Nortriptyline IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical

CVS Health - 00050428588697

14 Drugs Test Kit - Marijuana (THC50), Cocaine (COC300), Methamphetamine (MET1000), Phencyclidine (PCP25), Opiates (OPI2000), Amphetamine (AMP1000), Ecstasy (MDMA500), Tricyclic Antidepressants (TCA1000), Barbiturates (BAR300), Benzodiazepines (BZO300), Methadone (MTD300), Oxycodone (OXY300), Propoxyphene (PPX300), Buprenorphine (BUP10)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
346468
In Commercial Distribution

  • 00050428588697 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Nortriptyline IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent

CVS Health - 00050428368121

14 Drugs Test Kit - Marijuana (THC50), Cocaine (COC300), Methamphetamine (MET1000), Phencyclidine (PCP25), Opiates (OPI2000), Amphetamine (AMP1000), Ecstasy (MDMA500), Tricyclic Antidepressants (TCA1000), Barbiturates (BAR300), Benzodiazepines (BZO300), Methadone (MTD300), Oxycodone (OXY300), Propoxyphene (PPX300), Buprenorphine (BUP10)
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
346468
In Commercial Distribution

  • 00050428368121 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Nortriptyline IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, reagent
  • Oxycodone IVD, reagent

Precision DX - 00840050512432

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-274N
In Commercial Distribution

  • 00840050512432 ()


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

Precision DX - 00840050512418

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-265
In Commercial Distribution

  • 00840050512418 ()


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

Precision DX - 00840050512395

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-264N
In Commercial Distribution

  • 00840050512395 ()


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

Precision DX - 00840050512357

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA254NR
In Commercial Distribution

  • 00840050512357 ()


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

Precision DX - 00840050512272

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-234N
In Commercial Distribution

  • 00840050512272 ()


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

Precision DX - 00840050512241

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA2124N
In Commercial Distribution

  • 00840050512241 ()


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

Precision DX - 00840050512104

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-164N
In Commercial Distribution

  • 00840050512104 ()


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

Precision DX - 00840050512098

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-164N
In Commercial Distribution

  • 00840050512098 ()


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

Precision DX - 00840050512081

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-154N
In Commercial Distribution

  • 00840050512081 ()


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

Precision DX - 00840050512074

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-154N
In Commercial Distribution

  • 00840050512074 ()


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

Precision DX - 00840050512067

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-144N
In Commercial Distribution

  • 00840050512067 ()


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

Precision DX - 00840050512050

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-144N
In Commercial Distribution

  • 00840050512050 ()


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

Precision DX - 00840050512043

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA1384N
In Commercial Distribution

  • 00840050512043 ()


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

Precision DX - 00840050512036

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA1384N
In Commercial Distribution

  • 00840050512036 ()


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

Precision DX - 00840050512029

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA1374N
In Commercial Distribution

  • 00840050512029 ()


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

Precision DX - 00840050512012

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA1374N
In Commercial Distribution

  • 00840050512012 ()


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

Precision DX - 00840050512005

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA134N
In Commercial Distribution

  • 00840050512005 ()


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

Precision DX - 00840050511992

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA134N
In Commercial Distribution

  • 00840050511992 ()


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

Precision DX - 00840050511978

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA1274N
In Commercial Distribution

  • 00840050511978 ()


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

Precision DX - 00840050511862

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-114N
In Commercial Distribution

  • 00840050511862 ()


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

Precision DX - 00840050511855

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-114N
In Commercial Distribution

  • 00840050511855 ()


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

Precision DX - 00840050511848

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA1124N
In Commercial Distribution

  • 00840050511848 ()


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

Precision DX - 00840050511824

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DBA-114N
In Commercial Distribution

  • 00840050511824 ()


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

Precision DX - 00840050511794

No Description
AMERICAN SCREENING, L.L.C.
PREDX-CUP965N
In Commercial Distribution

  • 00840050511794 ()


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

Precision DX - 00840050511770

No Description
AMERICAN SCREENING, L.L.C.
PREDX-CUP9174N
In Commercial Distribution

  • 00840050511770 ()


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