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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 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
Rapid Response Blood Glucose Test Strips
BTNX Inc
04GLU-69NC
In Commercial Distribution

  • 00722066003190 ()
  • 00722066004708 ()


  • Glucose monitoring system IVD, home-use
Rapid Response Glucose Controls
BTNX Inc
04GLU-49
In Commercial Distribution

  • 00722066003183 ()


  • Glucose monitoring system IVD, home-use
Rapid Response™ Gluco-MD Blood Glucose Meter
BTNX Inc
04GLU-67NC
In Commercial Distribution

  • 00722066003176 ()


  • Glucose monitoring system IVD, home-use
Rapid Response Multi Drug Integrated Split Specimen Cups (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
D10.6-1G29-25
In Commercial Distribution

  • 00722066003107 ()
  • 00722066004142 ()
D10.6-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU) - 25 tests/ kit are for qualitative or semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine.
BTNX Inc
U10.1-1S25
In Commercial Distribution

  • 00722066003022 ()
  • 00722066003794 ()
U10.1-1S25

  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine pH IVD, kit, rapid colorimetric, clinical
  • Urine ketone IVD, kit, rapid colorimetric, clinical
  • Urine specific gravity IVD, kit, rapid colorimetric, clinical
  • Urine urobilinogen IVD, kit, rapid colorimetric, clinical
  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
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