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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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Tangle® Therapy
Tangle, Inc.
304
In Commercial Distribution

  • 00723459003049 ()


  • Finger/hand exerciser
Rapid Response 2 Parameter Urinalysis Reagent Strips (pH/S.g.) - 100 tests/ kit are for the qualitative or semi-quantitative detection of pH and specific gravity in urine.
BTNX Inc
U2.2-1S100
In Commercial Distribution

  • 00722066005231 ()
  • 00722066005248 ()


  • Urine pH IVD, kit, rapid colorimetric, clinical
  • Urine specific gravity IVD, kit, rapid colorimetric, clinical
Rapid Response Urinalysis Reagent Strips (Microalbumin/Creatinine)
BTNX Inc
U2.3-1S25
In Commercial Distribution

  • 00722066004388 ()
  • 00722066004418 ()


  • Microalbumin IVD, kit, rapid ICT, clinical
Rapid Response Urinary Tract Infection Test Strips - 3 Tests/ kit are for the detection of Nitrite and Leukocytes in urine.
BTNX Inc
UTI-1S1
In Commercial Distribution

  • 00722066003404 ()
  • 00722066003718 ()
UTI-1S1

  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Multiple urine analyte IVD, kit, rapid colorimetric, self-testing
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 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
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 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
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