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, 5-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
ASUD-254
In Commercial Distribution

  • 30850054867989 ()
  • 00850054867988 ()


  • Cocaine/cocaine 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
  • 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
UScreen™ RAPID DRUG TEST CUP, 14 Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUPA-14CLIA
In Commercial Distribution

  • 30850054867941 ()
  • 00850054867940 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite 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
UScreen™ RAPID DRUG TEST CUP, 10-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUP-10M
In Commercial Distribution

  • 30850054867934 ()
  • 00850054867933 ()


  • Methadone 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
  • 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
UScreen™ RAPID DRUG TEST CUP, 12-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUPA-12CLIA
In Commercial Distribution

  • 30850054867927 ()
  • 00850054867926 ()


  • Cocaine/cocaine 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
  • 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
UScreen™ RAPID DRUG TEST CUP, 12-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUPA-12BUP30
In Commercial Distribution

  • 30850054867910 ()
  • 00850054867919 ()


  • 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
UScreen™ RAPID DRUG TEST CUP, 12-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUPA-12NTCLIA
In Commercial Distribution

  • 30850054867903 ()
  • 00850054867902 ()


  • Cocaine/cocaine 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
  • 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
Guangzhou Decheng Biotechnology Co., LTD
ASUD-8135H
In Commercial Distribution

  • 00850054867841 ()


  • Cocaine/cocaine 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
  • 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, 8-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
NMCup-08-34-DK
In Commercial Distribution

  • 30850054867651 ()
  • 00850054867650 ()


  • Tricyclic antidepressant 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
  • 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, 11-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
NMCup-11-37-DK
In Commercial Distribution

  • 30850054867644 ()
  • 00850054867643 ()


  • 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
AllSource DRUG DETECTOR, 14-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
ALL8145R
In Commercial Distribution

  • 30850054867637 ()
  • 00850054867636 ()


  • 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
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