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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 DCA Vantage system is a semi-automated, benchtop system. It is designed to quantitatively measure the percent of Hemoglobin A1cin blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed usingthe DCA Vantage system are intended for in vitro diagnostic use.
Siemens Healthcare Diagnostics Inc.
10282969
In Commercial Distribution

  • 00630414551364 ()
5075US

  • Glycated haemoglobin (HbA1C) analyser IVD
AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function.
Siemens Healthcare Diagnostics Inc.
10324060
In Commercial Distribution

  • 00630414551142 ()
  • 00630414009544 ()
A2830C16

  • Urea IVD, kit, enzyme spectrophotometry
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen.
Siemens Healthcare Diagnostics Inc.
10339953
In Commercial Distribution

  • 00630414551111 ()
  • 00630414009735 ()
A2179B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Serum Tox 4 - ADVIA Chem. - CAL - 1x5mL
Siemens Healthcare Diagnostics Inc.
10283019
Not in Commercial Distribution

  • 00630414551081 ()
6520269

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Serum Tox 3 - ADVIA Chem. - CAL - 1x5mL
Siemens Healthcare Diagnostics Inc.
10283018
Not in Commercial Distribution

  • 00630414551074 ()
6520250

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Serum Tox ibrator 2 - ADVIA Chem. - CAL - 1x5mL
Siemens Healthcare Diagnostics Inc.
10283017
Not in Commercial Distribution

  • 00630414551067 ()
6520242

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Serum Tox ibrator 1 - ADVIA Chem. - CAL - 1x5mL
Siemens Healthcare Diagnostics Inc.
10283016
Not in Commercial Distribution

  • 00630414551050 ()
6520234

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Serum Tox Neg ibrator - ADVIA Chem. - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10283015
Not in Commercial Distribution

  • 00630414551043 ()
6520226

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Tricyclic Antidepressants - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10283014
Not in Commercial Distribution

  • 00630414551036 ()
6520218

  • Tricyclic antidepressant IVD, kit, enzyme immunoassay (EIA)
Methadone Metabolic - ADVIA Chem. - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10283006
Not in Commercial Distribution

  • 00630414550954 ()
6520080

  • 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, calibrator
Multi-Drug Urine Kit - ADVIA Chem. - CONS - 3x2x5mL
Siemens Healthcare Diagnostics Inc.
10282987
Not in Commercial Distribution

  • 00630414550916 ()
6520064

  • Multiple therapeutic drugs/drugs of abuse IVD, control
ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine.
Siemens Healthcare Diagnostics Inc.
10333485
In Commercial Distribution

  • 00630414550602 ()
  • 00630414009650 ()
A2191B16

  • Urine protein IVD, kit, rapid colorimetric, clinical
HEMASTIX® is a firm plastic strip to which is affixed a reagent area that tests for occult blood in urine. Test results may provide information on urinary tract status.
Siemens Healthcare Diagnostics Inc.
10312568
In Commercial Distribution

  • 00630414550596 ()
  • 00630414009353 ()
A2190B16

  • Urine blood IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.
Siemens Healthcare Diagnostics Inc.
10332782
In Commercial Distribution

  • 00630414549262 ()
  • 00630414009643 ()
A1566C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.
Siemens Healthcare Diagnostics Inc.
10331147
In Commercial Distribution

  • 00630414549255 ()
  • 00630414009636 ()
A1554C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein and glucose.
Siemens Healthcare Diagnostics Inc.
10339520
In Commercial Distribution

  • 00630414549132 ()
  • 00630414009728 ()
A2184B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, glucose and pH.
Siemens Healthcare Diagnostics Inc.
10337932
In Commercial Distribution

  • 00630414549125 ()
  • 00630414009704 ()
A2183B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose and pH.
Siemens Healthcare Diagnostics Inc.
10338451
In Commercial Distribution

  • 00630414549118 ()
  • 00630414009711 ()
A2182B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (aceto-acetic acietic acid) and pH
Siemens Healthcare Diagnostics Inc.
10337069
In Commercial Distribution

  • 00630414549101 ()
  • 00630414009674 ()
A2181B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, leukocytes, nitrite, glucose.
Siemens Healthcare Diagnostics Inc.
10312569
In Commercial Distribution

  • 00630414549057 ()
  • 00630414009377 ()
A2166B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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