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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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ADVIA® Chemistry HbA1c Denaturant Reagent - Manual Pretreat - 00630414555140

HbA1C Denaturant - ADVIA Chem. - CONS - 920mL (for 920 Tests)
Siemens Healthcare Diagnostics Inc.
10286032
Not in Commercial Distribution

  • 00630414555140 ()
4795367

  • Glycated haemoglobin (HbA1c) IVD, reagent

ADVIA Centaur® T3 - 00630414554631

T3 Total (Ref) - CENTAUR - RGT - 400 tests
Siemens Healthcare Diagnostics Inc.
10285734
In Commercial Distribution

  • 00630414554631 ()
  • 00630414010700 ()
4779779

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® T3 - 00630414554624

T3 Total - CENTAUR - RGT - 80 tests
Siemens Healthcare Diagnostics Inc.
10285733
In Commercial Distribution

  • 00630414554624 ()
4779671

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® T3 - 00630414554617

T3 Total - CENTAUR - RGT - 400 tests
Siemens Healthcare Diagnostics Inc.
10285732
In Commercial Distribution

  • 00630414554617 ()
  • 00630414003009 ()
4779663

  • Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry TOX Controls Toxicology Controls - 00630414553733

Serum Tox Kit - ADVIA Chem. - CTL - 6x5mL
Siemens Healthcare Diagnostics Inc.
10286267
Not in Commercial Distribution

  • 00630414553733 ()
4663525

  • Multiple therapeutic drugs/drugs of abuse IVD, control

RAPIDPoint® 405/500 Measurement Cartridge - 00630414553610

RAPIDPoint® 405/500 Measurement Cartridge (250 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10283222
In Commercial Distribution

  • 00630414553610 ()
10283222

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

RAPIDPoint® 405/500 Measurement Cartridge - 00630414553603

RAPIDPoint® 405/500 Measurement Cartridge (250 tests) - pH, pCO2, pO2, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10283221
In Commercial Distribution

  • 00630414553603 ()
10283221

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

ADVIA Centaur® FT4 MCM - 00630414553429

FT4 Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10283434
In Commercial Distribution

  • 00630414553429 ()
6872319

  • Free thyroxine (FT4) IVD, control

ADVIA® Chemistry UN_c Urea Nitrogen Reagents, Concentrated - 00630414553214

Urea Nitrogen - ADVIA Chem. - Conc. RGT - 4x2360 tests
Siemens Healthcare Diagnostics Inc.
10283349
In Commercial Distribution

  • 00630414553214 ()
6860558

  • Urea IVD, kit, enzyme spectrophotometry

ADVIA® Chemistry Total Protein Reagents Concentrated TP_c - 00630414553207

Total Protein - ADVIA Chem. - Conc. RGT - 4x3060 tests
Siemens Healthcare Diagnostics Inc.
10283348
In Commercial Distribution

  • 00630414553207 ()
6860531

  • Total protein IVD, kit, spectrophotometry

ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated - 00630414553191

Phosphorus inorganic - ADVIA Chem. - Conc. RGT - 6x1700 tests
Siemens Healthcare Diagnostics Inc.
10283347
In Commercial Distribution

  • 00630414553191 ()
6860523

  • Inorganic phosphate (PO43-) IVD, kit, spectrophotometry

ADVIA® Chemistry CRE_2c Creatinine Reagents, Concentrated - 00630414553184

Creatinine Jaffe - ADVIA Chem. - Conc. RGT - 4x2360 tests
Siemens Healthcare Diagnostics Inc.
10283346
In Commercial Distribution

  • 00630414553184 ()
6860515

  • Creatinine IVD, kit, spectrophotometry

ADVIA® Chemistry CO2_c Reagents Concentrated - 00630414553177

CO2 enzymatic - ADVIA Chem. - Conc. RGT - 7520 tests
Siemens Healthcare Diagnostics Inc.
10283345
In Commercial Distribution

  • 00630414553177 ()
  • 00630414002958 ()
6860507

  • Carbon dioxide (CO2) IVD, kit, spectrophotometry

ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo III - 00630414553160

Calcium - ADVIA Chem. - RGT - 4x1700 tests
Siemens Healthcare Diagnostics Inc.
10283344
In Commercial Distribution

  • 00630414553160 ()
  • 00630414002941 ()
6860493

  • Calcium (Ca2+) IVD, kit, spectrophotometry

ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated - 00630414553153

AST/GOT - ADVIA Chem. - Conc. RGT - 6x850 tests
Siemens Healthcare Diagnostics Inc.
10283343
In Commercial Distribution

  • 00630414553153 ()
6860485

  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry

ADVIA® Chemistry P5P_c Pyridoxal-5-Phosphate Reagents - 00630414553146

ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 tests
Siemens Healthcare Diagnostics Inc.
10283342
Not in Commercial Distribution

  • 00630414553146 ()
  • 00630414002934 ()
6860477

  • Alanine aminotransferase (ALT) IVD, reagent

ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated - 00630414553139

ALT/GPT - ADVIA Chem. - Conc. RGT - 6x850 tests
Siemens Healthcare Diagnostics Inc.
10283341
In Commercial Distribution

  • 00630414553139 ()
6860469

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry

ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein - 00630414552699

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

ADVIA® Chemistry CRP_2 Reagents - 00630414552118

CRP - ADVIA Chem. - RGT - 4x250 tests
Siemens Healthcare Diagnostics Inc.
10283129
In Commercial Distribution

  • 00630414552118 ()
6522059

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry D-HDL Direct HDL Cholesterol Reagents - 00630414551784

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

ADVIA Centaur® Systems aHBs2 QC - 00630414551777

Anti-HBs2 (aHBs2) Quality Control Material
Siemens Healthcare Diagnostics Inc.
10283088
In Commercial Distribution

  • 00630414551777 ()
6521435

  • Hepatitis B virus surface total antibody IVD, control

ADVIA Centaur® SHBG - 00630414551548

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

ADVIA Centaur® SHBG MCM - 00630414551531

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

DCA Vantage® Analyzer - 00630414551364

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® Reagent Strips - 00630414551142

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

Multistix® Reagent Strips - 00630414551111

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

ADVIA® Chemistry TOX CAL 4 - 00630414551081

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

ADVIA® Chemistry TOX CAL 3 - 00630414551074

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

ADVIA® Chemistry TOX CAL 2 - 00630414551067

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

ADVIA® Chemistry TOX CAL 1 - 00630414551050

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

ADVIA® Chemistry TOX NEG Calibrator - 00630414551043

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

ADVIA® Chemistry TCA - 00630414551036

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)

ADVIA® Chemistry METMTB Calibrator - Urine - 00630414550954

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

ADVIA® Chemistry Multi-Drug Urine Controls 1,2 - 00630414550916

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® Reagent Strips - 00630414550602

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® Reagent Strips - 00630414550596

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

Multistix PRO® 10LS Reagent Strips - 00630414549262

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

Multistix PRO® 10LS Reagent Strips - 00630414549255

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

Uristix® Reagent Strips - 00630414549132

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

Combistix® Reagent Strips - 00630414549125

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

Hema-Combistix® Reagent Strips - 00630414549118

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

Labstix® Reagent Strips - 00630414549101

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

Uristix® 4 Reagent Strips - 00630414549057

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

Multistix® 7 Reagent Strips - 00630414549040

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

Multistix® 8 SG Reagent Strips - 00630414549033

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

Multistix® 9 SG Reagent Strips - 00630414549026

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

Multistix® 9 Reagent Strips - 00630414549019

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

Multistix® 10 SG Reagent Strips - 00630414548968

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 - 00630414548951

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 SP - 00630414541457

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
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