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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 4 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein in urine.
BTNX Inc
U4.1-1S100
In Commercial Distribution

  • 00722066000366 ()
  • 00722066003756 ()
U4.1-1S100

  • 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
Rapid Response 2 Parameter Urinalysis Reagent Strips (Glu/Pro) - 100 tests/ kit are for the qualitative or semi-quantitative detection of Glucose and Protein in urine.
BTNX Inc
U2.1-1S100
In Commercial Distribution

  • 00722066000342 ()
  • 00722066003732 ()
U2.1-1S100

  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
Rapid Response 1 Parameter Urinalysis Reagent Strips (Ketone) - 100 strips/ kit are for the qualitative or semi-quantitative detection of Ketone in urine.
BTNX Inc
U-KET-1S100
In Commercial Distribution

  • 00722066000335 ()
  • 00722066003725 ()
U-KET-1S100

  • Urine ketone IVD, kit, rapid colorimetric, clinical
Rapid Response Mononucleosis Test Cassettes - 15 tests/ kit are for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma.
BTNX Inc
MON-13C15
In Commercial Distribution

  • 00722066000311 ()
  • 00722066004272 ()
MON-13C15

  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution

  • 00722066000304 ()
  • 00722066004258 ()
HPY-13C15

  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitative detection of human chorionic gonadotropin in urine.
BTNX Inc
HCG-1C25
In Commercial Distribution

  • 00722066000274 ()
  • 00722066004166 ()
HCG-1C25

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response hCG Pregnancy Test Cassettes - 25 tests/ kit are for the qualitative detection of Human Chorionic Gonadotropin in urine/ serum,
BTNX Inc
HCG-3C25
In Commercial Distribution

  • 00722066000267 ()
  • 00722066004203 ()
HCG-3C25

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of human chorionic gonadotropin in urine.
BTNX Inc
HCG-1C50
In Commercial Distribution

  • 00722066000229 ()
  • 00722066004173 ()
HCG-1C50

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of Human Chlorionic Gonadotropin in urine/ serum.
BTNX Inc
HCG-3C50
In Commercial Distribution

  • 00722066000205 ()
  • 00722066004210 ()
HCG-3C50

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Rapid Response Strep A Test Strips (throat swab) - 25 tests/ kit are for qualitative detection of Group A Streptococcal antigen from throat swab specimens.
BTNX Inc
STR-15S25
In Commercial Distribution

  • 00722066000014 ()
  • 00722066004234 ()
STR-15S25

  • Beta-haemolytic Group A Streptococcus streptokinase antibody IVD, kit, enzyme immunoassay (EIA)
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