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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 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
Rapid Response Multi Drug Test Panels (AMP/COC/THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D3.14-1P29-25
In Commercial Distribution

  • 00722066003428 ()
  • 00722066003954 ()
D3.14-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Urinary Tract Infection Test Strips - 3 Tests/ kit are for the detection of Nitrite and Leukocytes in urine.
BTNX Inc
UTI-1S1
In Commercial Distribution

  • 00722066003404 ()
  • 00722066003718 ()
UTI-1S1

  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Multiple urine analyte IVD, kit, rapid colorimetric, self-testing
Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of Influenza A and B Virus Antigens in nasal specimens.
BTNX Inc
FLUab-19C15
In Commercial Distribution

  • 00722066003343 ()
  • 00722066004241 ()
FLUab-19C15

  • Influenza A/B virus antigen 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
Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qualitative detection of Human Chorionic Gonadotropin in urine/ serum.
BTNX Inc
HCG-3S100
In Commercial Distribution

  • 00722066003244 ()
  • 00722066004227 ()
HCG-3S100

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response Blood Glucose Lancets
BTNX Inc
04GLU-47
In Commercial Distribution

  • 00722066003213 ()
  • 00722066004685 ()


  • Glucose monitoring system IVD, home-use
Rapid Response Lancing Device
BTNX Inc
04GLU-48
In Commercial Distribution

  • 00722066004692 ()
  • 00722066003206 ()


  • Glucose monitoring system IVD, home-use
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