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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 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
Rapid Response Multi Drug Integrated Split Specimen Cup (COC/MET/THC/OPI/PCP) - 25 tests/ kit are for the qualitative detection of Methamphetamine, Opiates, Phencyclidine, Cocaine and THC metabolites in urine.
BTNX Inc
D5.3-1G29-25
In Commercial Distribution

  • 00722066000885 ()
  • 00722066004104 ()
D5.3-1G29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panel (AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/TCA/THC) - 25 tests/ kit are for qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.1-1P29-25
In Commercial Distribution

  • 00722066000847 ()
  • 00722066004029 ()
D10.1-1P29-25

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

  • 00722066000830 ()
  • 00722066004005 ()
D6.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/OPI/THC) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Opiates, THC and Cocaine metabolites in urine.
BTNX Inc
D5.1-1P29-25
In Commercial Distribution

  • 00722066000809 ()
  • 00722066003992 ()
D5.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/THC/AMP/OPI) - 25 tests/ kit are for the qualitative detection of Amphetamine, Opiates, THC and Cocaine metabolites in urine.
BTNX Inc
D4.1-1P29-25
In Commercial Distribution

  • 00722066000793 ()
  • 00722066003985 ()
D4.1-1P29-25

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