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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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The Rapid Response hCG Pregnancy Midstream Test is a rapid, self-performing, qualitative test for the determination of human chorionic gonadotropin in human urine specimens, to aid in the early detection of pregnancy.
BTNX Inc
HCG-1M1
In Commercial Distribution

  • 00722066005323 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
3 Panel One Step DOA Cup(3.36) - COC300 AMP1000 MET1000
BTNX Inc
D3.36-1V
In Commercial Distribution

  • 00722066005309 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response 11 Parameter Urinalysis Reagent Strips (ASC/GLU/BLD/LEU/PRO/NIT/KET/PH/BIL/URO/SG) - 100 tests/ kit are for qualitative or semi-quantitative determination of Ascorbic Acid, Glucose, Blood, Leukocyte, Protein, Nitrite, Ketone, pH, Bilirubin, Urobilinogen, Specific Gravity in urine.
BTNX Inc
U11.1-1S100
In Commercial Distribution

  • 00722066005255 ()
  • 00722066005262 ()


  • Urine specific gravity IVD, kit, rapid colorimetric, clinical
  • Urine pH 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
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine ketone IVD, kit, rapid colorimetric, clinical
  • Urine urobilinogen IVD, kit, rapid colorimetric, clinical
  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
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
One Step 5 Panel DOA Cup (5.75) - COC300 MET1000 AMP1000 OPI2000 OXY100
BTNX Inc
D5.75-1V
In Commercial Distribution

  • 00722066005095 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step 10 Panel DOA Cup (10.32) - COC300 MET1000 AMP1000 OPI2000 OXY100 MTD300 PCP25 BAR300 BZO300 MDMA500
BTNX Inc
D10.32-1V
In Commercial Distribution

  • 00722066005088 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step DOA Cup + Adulteration Test (5.30.1) COC(150) EDDP(100) MOP(100) OXY(100) BZO(300) + CR/SG/pH
BTNX Inc
D5.30.1-1VA
In Commercial Distribution

  • 00722066005019 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response FIT Mailers&Buffers&Cassettes - 36 Mailers + Buffers + Cassettes/Box
BTNX Inc
FOB-0MBC
In Commercial Distribution

  • 00722066004999 ()
  • 00722066004982 ()


  • Faecal occult blood IVD, kit, rapid ICT, clinical
Single Drug Test Strip - 100/kit - Barbiturate
BTNX Inc
BAR-1S3-100
In Commercial Distribution

  • 00722066004968 ()
  • 00722066004975 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Drug Test Strip - 100/kit Methadone (MTD) - Cut-off 300 ng/ml
BTNX Inc
MTD-1S3-100
In Commercial Distribution

  • 00722066004951 ()
  • 00722066004944 ()


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