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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™ 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
Rapid Response Respiratory Syncytial Virus Test Cassette - 30 tests/ kit are for the qualitative detection of Respiratory Syncytial Virus Antigen in Nasopharyngeal specimens.
BTNX Inc
RSV-19C30
In Commercial Distribution

  • 00722066001974 ()
  • 00722066004265 ()
RSV-19C30

  • Influenza virus/respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT), rapid
Thyroid TSH Test Controls +/- Controls Serum 0.5 mL
BTNX Inc
TSH-CTRL-13V
In Commercial Distribution

  • 00722066001950 ()


  • Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)
Urine Analyzer 120
BTNX Inc
U120
In Commercial Distribution

  • 00722066001936 ()
  • 00722066005064 ()


  • Urine analyser IVD, point-of-care
Liquid Diptube Urine ControlsLiquid Diptube Urine Ctl Set
BTNX Inc
AUCT-1V1
In Commercial Distribution

  • 00722066001912 ()


  • Multiple urine analyte IVD, control
Rapid Response Adenovirus Test Cassettes - 20 tests/ kit are for the qualitative detection of various adenovirus in fecal samples.
BTNX Inc
ADE-9C20
In Commercial Distribution

  • 00722066001905 ()
  • 00722066004296 ()
ADE-9C20

  • Adenovirus antigen IVD, kit, rapid ICT, clinical
Rapid Response Rotavirus Test Cassettes - 20 tests/ kit are for qualitative detection of rotavirus antigens in fecal specimens.
BTNX Inc
ROT-9C20
In Commercial Distribution

  • 00722066001899 ()
  • 00722066004289 ()
ROT-9C20

  • Rotavirus antigen IVD, kit, rapid ICT, clinical
Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative detection of human hemoglobin in feces.
BTNX Inc
FOB-9C36
In Commercial Distribution

  • 00722066001882 ()
  • 00722066004302 ()
  • 10722066001889 ()
FOB-9C36

  • Faecal occult blood IVD, kit, rapid ICT, clinical
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