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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 - 00722066000489

Single Drug Test Strip - 100/kit - Buprenorphine
BTNX Inc
BUP-1S5-100
Not in Commercial Distribution

  • 00722066000489 ()
  • 00722066004715 ()


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

Rapid Response - 00722066000458

Rapid Response Single Drug Test Strips (AMP) - 100 tests/ kit are for the qualitative detection of Amphetamine 1000 ng/ml in urine.
BTNX Inc
AMP-1S2-100
In Commercial Distribution

  • 00722066000458 ()
  • 00722066003930 ()
AMP-1S2-100

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

Rapid Response - 00722066000441

Rapid Response Single Drug Test Cassettes (Amphetamine) - 40 tests/ kit are for the qualitative detection of Amphetamine in urine.
BTNX Inc
AMP-1C2-40
In Commercial Distribution

  • 00722066000441 ()
  • 00722066003923 ()
AMP-1C2-40

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

Rapid Response - 00722066000380

Rapid Response 7 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT/KET/PH) - 100 tests/ kit are for qualitative/ semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite, Ketone and pH in urine.
BTNX Inc
U7.1-1S100
In Commercial Distribution

  • 00722066000380 ()
  • 00722066003770 ()
U7.1-1S100

  • 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

Rapid Response - 00722066000373

Rapid Response 5 Parameter Urinalysis Reagent Strips (GLU/BLD/LEU/PRO/NIT) - 100 tests/ kit are for qualitative or semi-quantitative determination of Glucose, Blood, Leukocytes, Protein, Nitrite in urine.
BTNX Inc
U5.1-1S100
In Commercial Distribution

  • 00722066000373 ()
  • 00722066003763 ()
U5.1-1S100

  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • 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 - 00722066000366

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 - 00722066000342

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 - 00722066000335

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 - 00722066000311

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 - 00722066000304

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
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