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, 12-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
ASUD-3124
In Commercial Distribution

  • 30850054867255 ()
  • 00850054867254 ()


  • 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
  • Methamphetamine-specific 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
  • 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-254
In Commercial Distribution

  • 30850054867248 ()
  • 00850054867247 ()


  • 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
  • Methamphetamine-specific 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
  • 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-2135A3
In Commercial Distribution

  • 30850054867231 ()
  • 00850054867230 ()


  • Methamphetamine-specific 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
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
Amazewell™ Multi-Drug Urine Test Clicker Cup, 14-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
ASUD-1145A3
In Commercial Distribution

  • 30850054867224 ()
  • 00850054867223 ()


  • Methamphetamine-specific 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
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
UScreen™ RAPID DRUG TEST CUP, 13-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUP-13CLIA
In Commercial Distribution

  • 30850065976168 ()
  • 00850065976167 ()


  • 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
  • Methamphetamine-specific 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
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
UScreen™ RAPID DRUG TEST CUP, 13-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUPA-13CLIA
In Commercial Distribution

  • 30850065976151 ()
  • 00850065976150 ()


  • 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
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite 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
USSCUPA-10MOB-300
In Commercial Distribution

  • 30850065976137 ()
  • 00850065976136 ()


  • 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
  • Methamphetamine-specific 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
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
UScreen™ RAPID DRUG TEST CUP, 10-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUPA-10NT
In Commercial Distribution

  • 30850065976120 ()
  • 00850065976129 ()


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

  • 30850065976113 ()
  • 00850065976112 ()


  • 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
  • Methamphetamine-specific 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
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
UScreen™ RAPID DRUG TEST CUP, 5-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
USSCUPA-5M
In Commercial Distribution

  • 30850065976106 ()
  • 00850065976105 ()


  • 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
  • Methamphetamine-specific 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
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
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