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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 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
Rapid Response Thyroid Stimulating Hormone Test Cassettes - 20 tests/ kit are for the qualitative detection of TSH in serum, plasma or whole blood.
BTNX Inc
TSH-13C20
In Commercial Distribution

  • 00722066001646 ()
  • 00722066004319 ()
TSH-13C20

  • Thyroid stimulating hormone (TSH) IVD, kit, enzyme immunoassay (EIA)
Urine Analyzer 500
BTNX Inc
UA-500
In Commercial Distribution

  • 00722066001219 ()
  • 00722066005071 ()


  • Urine analyser IVD, point-of-care
Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qulitative detection of Human Chorionic Gonadotropin in urine.
BTNX Inc
HCG-1S100
In Commercial Distribution

  • 00722066001202 ()
  • 00722066004197 ()
HCG-1S100

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response 10 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine.
BTNX Inc
U10.1-1S100
In Commercial Distribution

  • 00722066001172 ()
  • 00722066003787 ()
U10.1-1S100

  • 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 hCG Pregnancy Test Strips - 50 tests/ kit are for the qulitative detection of Human Chorionic Gonadotropin in urine.
BTNX Inc
HCG-1S50
In Commercial Distribution

  • 00722066001042 ()
  • 00722066004180 ()
HCG-1S50

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/OPI/PCP/BAR/BZO/MTD/MDMA) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Opiates, Phencyclidine, Barbiturates, Benzodiazepines, Methadone, 3,4-Methylenedioxy-Methamphetamine, Cocaine and THC metabolites in urine.
BTNX Inc
D10.3-1G29-25
In Commercial Distribution

  • 00722066000915 ()
  • 00722066004135 ()
D10.3-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
Rapid Response Multi Drug Integrated Split Specimen Cups (COC,AMP,MET,THC,OPI,BZO) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Opiates, Benzodiazepines, Cocaine and THC metabolites in urine.
BTNX Inc
D6.1-1G29-25
In Commercial Distribution

  • 00722066000892 ()
  • 00722066004111 ()
D6.1-1P29-25

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