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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 5 Parameter Urinalysis Reagent Strips (KET/PH/PRO/GLU/BLD) – 100 tests/ kit are for qualitative or semi-quantitative determination of Ketone, pH, Protein, Glucose and Blood in urine.
BTNX Inc
U5.3-1S100
In Commercial Distribution

  • 00722066004364 ()
  • 00722066004371 ()
U5.3-1S100

  • Urine pH IVD, kit, rapid colorimetric, clinical
  • Urine ketone IVD, kit, rapid colorimetric, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Morphine, Oxycodone, Propoxyphene, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.1-1G29-25
In Commercial Distribution

  • 00722066003701 ()
  • 00722066004159 ()
D12.1-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug One Step Cup (AMP/BAR/BUP/BZO/COC/MDMA/MTD/MET/OPI/OXY/THC/PCP) - 25 Tests/ kit are for the qualitative detection of Amphetamine, Barbiturate, Buprenorphine, Bezodiazepines, 3,4-Methylenedioxy-Methamphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.5-1T
In Commercial Distribution

  • 00722066003695 ()
  • 00722066004098 ()
D12.5-1T

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panel (Amphetamine, Barbiturate, Buprenorphine, Benzodiazepine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D12.2-1P29-25
In Commercial Distribution

  • 00722066003688 ()
  • 00722066004074 ()
D12.2-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BZO/BAR) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Opiates, Oxycodone, Propoxyphene, Phencyclidine, Benzodiazepines, Barbiturate, Cocaine and THC metabolites in urine.
BTNX Inc
D12.8-1P29-25
In Commercial Distribution

  • 00722066003671 ()
  • 00722066004081 ()
D12.8-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/PCP/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D11.3-1P29-25
In Commercial Distribution

  • 00722066003664 ()
  • 00722066004050 ()
D11.3-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D10.12-1P29-25
In Commercial Distribution

  • 00722066003657 ()
  • 00722066004036 ()
D10.12-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Microalbumin Creatinine Test Strips- 25 tests/kit are for semi-quantitative determination of Albumin and Creatinine in urine.
BTNX Inc
U2.3-1S25
Not in Commercial Distribution

  • 00722066003640 ()
  • 00722066003749 ()
U2.3-1S25

  • Urine creatinine IVD, kit, rapid colorimetric, clinical
  • Microalbumin IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Morphine, Oxycodone, Propoxyphene, Barbiturate, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.1-1P29-25
In Commercial Distribution

  • 00722066003541 ()
  • 00722066004067 ()
D12.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/OPI/MDMA) - 25 tests/ kit are for qualitative detection of Amphetamine, Methamphetamine, Opiates, 3,4-Methyoxydiene-Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D6.14-1P29-25
In Commercial Distribution

  • 00722066003459 ()
  • 00722066004012 ()
D6.14-1P29-25

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