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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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
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 1 - ADVIA Chem. - CAL - 1x5mL
Siemens Healthcare Diagnostics Inc.
10283016
Not in Commercial Distribution

  • 00630414551050 ()
6520234

  • 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)
TSH - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10282379
In Commercial Distribution

  • 00630414535654 ()
6491080

  • 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
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
DCA Microablumin Creatinine Test Kit (ACR test).
Siemens Healthcare Diagnostics Inc.
10311480
In Commercial Distribution

  • 00630414532790 ()
6011A

  • Microalbumin IVD, kit, spectrophotometry
Valproic Acid Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322232
Not in Commercial Distribution

  • 00630414527369 ()
5261307

  • Valproic acid therapeutic drug monitoring IVD, control
Valproic Acid - CENTAUR - CAL - 6x6x5mL
Siemens Healthcare Diagnostics Inc.
10322227
Not in Commercial Distribution

  • 00630414527352 ()
5260521

  • Valproic acid therapeutic drug monitoring IVD, calibrator
Valproic Acid - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10322222
Not in Commercial Distribution

  • 00630414527345 ()
5259132

  • Valproic acid therapeutic drug monitoring IVD, calibrator
Valproic Acid - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322218
Not in Commercial Distribution

  • 00630414527338 ()
  • 00630414027647 ()
5258292

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Valproic Acid - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10322215
Not in Commercial Distribution

  • 00630414527321 ()
5256877

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Gentamicin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10322163
Not in Commercial Distribution

  • 00630414527307 ()
5227559

  • Gentamicin therapeutic drug monitoring IVD, control
Gentamicin - CENTAUR - CAL - 6x6x2mL
Siemens Healthcare Diagnostics Inc.
10322161
Not in Commercial Distribution

  • 00630414527291 ()
5226870

  • Gentamicin therapeutic drug monitoring IVD, calibrator
Gentamicin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10322159
Not in Commercial Distribution

  • 00630414527284 ()
5226110

  • Gentamicin therapeutic drug monitoring IVD, calibrator
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