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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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Rapid Response Multi Drug Integrated Split Specimen Cup (AMP,BAR,BZO,COC,MET,MTD,OPI,PCP,TCA,THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic-Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.1-1G29-25
In Commercial Distribution

  • 00722066000908 ()
  • 00722066004128 ()
D10.1-1G29

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Urine Cannabinoids Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445116
In Commercial Distribution

  • 00842768015441 ()
  • 00630414004891 ()
K5095

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Clinical Guard
THC Marijuana Drug Test Strip
In Commercial Distribution

  • 00851950008123 ()
  • 00851950008062 ()
  • 10851950008120 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC-COOH 25 NG/ML
UTAK LABORATORIES, INC.
THC 25 U F SDHL
In Commercial Distribution

  • B800THC25UFSDHL5 ()
  • B800THC25UFSDHL0 ()

  • Total Volume: 10 Milliliter
THC 25 U F SDHL

  • Multiple drugs of abuse IVD, control
THC-COOH 1000 NG/ML
UTAK LABORATORIES, INC.
THC 1000 U F SDHL
In Commercial Distribution

  • B800THC1000UFSDHL5 ()
  • B800THC1000UFSDHL0 ()

  • Total Volume: 10 Milliliter
THC 1000 U F SDHL

  • Multiple drugs of abuse IVD, control
BluRapids Concise CLIA Waived Drug Cup; 12-Panel; AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/THC
MERCEDES MEDICAL, LLC
TNR CDOA6125M
In Commercial Distribution

  • 10850011007294 ()
  • 00850011007297 ()
  • 00850011007280 ()
TNR CDOA6125M

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Tanner Scientific CLIA waived 13 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR DOA13A
In Commercial Distribution

  • 20850011007130 ()
  • 10850011007133 ()
  • 00850011007136 ()
TNR DOA13A

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Oxycodone 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
Tanner Scientific CLIA waived Drug Cup; 12Panel AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/THC
MERCEDES MEDICAL, LLC
TNR DOA12A
In Commercial Distribution

  • 20850011007123 ()
  • 10850011007126 ()
  • 00850011007129 ()
TNR DOA12A

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, liquid chromatography
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR CDOA7125
In Commercial Distribution

  • 00850011007082 ()
  • 10850011007089 ()
  • 20850011007086 ()
TNR CDOA7125

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-300/OXY/ PCP/THC
MERCEDES MEDICAL, LLC
TNR CDOA6125
In Commercial Distribution

  • 00850011007068 ()
  • 10850011007065 ()
  • 20850011007062 ()
TNR CDOA6125

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
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