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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CRP Cardiophase - ADVIA Chem. - RGT - 2x220 tests
Siemens Healthcare Diagnostics Inc.
10283282
In Commercial Distribution

  • 00630414552699 ()
6837459

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
CRP - ADVIA Chem. - RGT - 4x250 tests
Siemens Healthcare Diagnostics Inc.
10283129
In Commercial Distribution

  • 00630414552118 ()
6522059

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry
HDL Cholesterol - ADVIA Chem. - RGT - 6x670 tests
Siemens Healthcare Diagnostics Inc.
10283089
In Commercial Distribution

  • 00630414551784 ()
6521559

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
Anti-HBs2 (aHBs2) Quality Control Material
Siemens Healthcare Diagnostics Inc.
10283088
In Commercial Distribution

  • 00630414551777 ()
6521435

  • Hepatitis B virus surface total antibody IVD, control
SHBG - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10283087
Not in Commercial Distribution

  • 00630414551548 ()
6520781

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
SHBG Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10283086
Not in Commercial Distribution

  • 00630414551531 ()
6520773

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
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
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid) and pH.
Siemens Healthcare Diagnostics Inc.
10326145
In Commercial Distribution

  • 00630414549040 ()
  • 00630414009582 ()
A2165C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH and specific gravity.
Siemens Healthcare Diagnostics Inc.
10337913
In Commercial Distribution

  • 00630414549033 ()
  • 00630414009698 ()
A2164C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity and bilirubin
Siemens Healthcare Diagnostics Inc.
10337216
In Commercial Distribution

  • 00630414549026 ()
  • 00630414009681 ()
A2163B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen
Siemens Healthcare Diagnostics Inc.
10329874
In Commercial Distribution

  • 00630414549019 ()
  • 00630414009629 ()
A2162B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity, bilirubin and urobilinogen.
Siemens Healthcare Diagnostics Inc.
10336425
In Commercial Distribution

  • 00630414548968 ()
  • 00630414009667 ()
A2161B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
CLINITEK® Microalbumin 2 Reagent Strips are firm plastic strips that contain two reagent pads that test for albumin and creatinine in urine.
Siemens Healthcare Diagnostics Inc.
10317439
In Commercial Distribution

  • 00630414548951 ()
  • 00630414009452 ()
A2083C24

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
VERSANT® kPCR Molecular System Sample Preparation Instrument Module
Siemens Healthcare Diagnostics Inc.
10282928
In Commercial Distribution

  • 00630414541457 ()
53982-01

  • Nucleic acid sample preparation instrument IVD
Calcium - ADVIA Chem. - RGT - 4x1450 tests
Siemens Healthcare Diagnostics Inc.
10282576
In Commercial Distribution

  • 00630414538716 ()
6502821

  • Calcium (Ca2+) IVD, kit, spectrophotometry
For use with the in vitro diagnostic Hema-Chek® Slide Test for the Qualitatitive Determination of Fecal Occult Blood.
Siemens Healthcare Diagnostics Inc.
10313614
In Commercial Distribution

  • 00630414538396 ()
  • 00630414009407 ()
2596

  • Faecal occult blood IVD, kit, rapid colorimetric, clinical
Slide based In vitro diagnostics reagent tests for the Qualitative Determination of Fecal Occult Blood.
Siemens Healthcare Diagnostics Inc.
10313436
In Commercial Distribution

  • 00630414538389 ()
2592

  • Faecal occult blood IVD, kit, rapid colorimetric, clinical
The DCA Microalbumin Creatinine Control Kit contains both Low Controls and High Controls. Each control is a buffered aqueous solution containing known amounts of human albumin and creatinine. The resulting mixture is then lyophilized to ensure stability. The DCA Microalbumin Creatinine Control Kit has been designed for use with the DCA Microalbumin Creatinine Reagent Kit.
Siemens Healthcare Diagnostics Inc.
10325406
In Commercial Distribution

  • 00630414535722 ()
6012A

  • Microalbumin IVD, control
TSH - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10282379
In Commercial Distribution

  • 00630414535654 ()
6491080

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10282378
In Commercial Distribution

  • 00630414535647 ()
6491072

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Free T4 (REF) - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10282220
In Commercial Distribution

  • 00630414535432 ()
  • 00630414002927 ()
6490114

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free T4 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10282219
In Commercial Distribution

  • 00630414535425 ()
  • 00630414002910 ()
6490106

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
Free T4 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10282218
In Commercial Distribution

  • 00630414535418 ()
6490092

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
DHEA-S Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10282214
In Commercial Distribution

  • 00630414535340 ()
6489752

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
DHEA-S - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10282227
In Commercial Distribution

  • 00630414535333 ()
6489701

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
ADVIA® 1800 Instrument
Siemens Healthcare Diagnostics Inc.
10315183
In Commercial Distribution

  • 00630414534794 ()
073-A021-01

  • Multiple clinical chemistry analyser IVD, laboratory
CRP 2 - ADVIA Chem. - CAL - 6x1mL
Siemens Healthcare Diagnostics Inc.
10337471
In Commercial Distribution

  • 00630414534244 ()
6487741

  • C-reactive protein (CRP) IVD, calibrator
Microalbumin - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10337470
In Commercial Distribution

  • 00630414534077 ()
6487733

  • Microalbumin IVD, calibrator
Quality control for Siemens urine strips read visually and all analyzers other than Clinitek Atlas® and Clinitek Novus® - 25 positive strips
Siemens Healthcare Diagnostics Inc.
10310482
In Commercial Distribution

  • 00630414532844 ()
  • 00630414009230 ()
1360

  • Multiple urine analyte IVD, control
Quality control for Siemens urine strips read visually and all analyzers other than Clinitek Atlas® and Clinitek Novus® - 25 positive and 25 negative strips
Siemens Healthcare Diagnostics Inc.
10310483
In Commercial Distribution

  • 00630414532837 ()
1364

  • Multiple urine analyte IVD, control
DCA HbA1c Test Kit (monitoring only) - INTL.
Siemens Healthcare Diagnostics Inc.
10311134
In Commercial Distribution

  • 00630414532806 ()
5035C

  • Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography
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