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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 Centaur® ACS:180® Calibrator A - 00630414555324

Thyroid (6PK) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285904
In Commercial Distribution

  • 00630414555324 ()
4800735

  • Multiple human hormone IVD, calibrator

ADVIA Centaur® ACS:180® Calibrator A - 00630414555317

Thyroid (2PK) - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10285903
In Commercial Distribution

  • 00630414555317 ()
4800646

  • Multiple human hormone IVD, calibrator

ADVIA Centaur® Systems aHBs2 MCM - 00630414555300

aHBs2 Master Curve Material
Siemens Healthcare Diagnostics Inc.
10285962
In Commercial Distribution

  • 00630414555300 ()
4800387

  • Hepatitis B virus surface total antibody IVD, control

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
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