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 Class Implantable

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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™ 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 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™ 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
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 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
FDA Clia Waived, 25T, MOP300/MDMA500/OXY100/PCP25/COC150/MTD300/BAR300/BZO300/AMP500/MET500/TCA1000/THC50/BUP10/FYL1 + (OXI/SG/PH)+(NIT/GLU/CRE)
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983168649 ()
  • 16936983168646 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/TCA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.6-1P29-25
In Commercial Distribution

  • 00722066003312 ()
  • 00722066004043 ()
D10.6-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1T,FDA,CLIA waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/BUP10+CRE/SG/PH
Hangzhou AllTest Biotech Co., Ltd.
DUA-A1127C-A3 A1617
In Commercial Distribution

  • 16936983149751 ()
DISP-DUD20125N$

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Multi-Drug 14 Drugs Rapid Test Cup(Urine), 25T, FDA,CLIA waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/EDDP300/THC50/BUP10+CRE/SG/PH
Hangzhou AllTest Biotech Co., Ltd.
DISP-DUD6144N$
In Commercial Distribution

  • 06936983144674 ()
  • 16936983144671 ()


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