SEARCH RESULTS FOR: siemens(7217 results)

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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 VPA_2 Valproic Acid_2 Reagents - 00630414561950

Valproic Acid - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377508
In Commercial Distribution

  • 00630414561950 ()
10377508

  • Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry GENT_2 Gentamicin_2 Reagents - 00630414561943

Gentamicin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377507
In Commercial Distribution

  • 00630414561943 ()
10377507

  • Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry PHNY_2 Phenytoin_2 Reagents - 00630414561936

Phenytoin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377506
In Commercial Distribution

  • 00630414561936 ()
10377506

  • Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry PHNB_2 Phenobarbital_2 Reagents - 00630414561929

Phenobarbital - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377505
In Commercial Distribution

  • 00630414561929 ()
10377505

  • Phenobarbital therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry THEO_2 Theophylline_2 Reagents - 00630414561905

Theophyline - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377503
In Commercial Distribution

  • 00630414561905 ()
10377503

  • Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry GLUH_c Glucose Hexokinase_3 Reagents, Concentrated - 00630414561899

Glucose - ADVIA Chem. - Conc. RGT - 4x2100/4x1600 tests
Siemens Healthcare Diagnostics Inc.
10377502
In Commercial Distribution

  • 00630414561899 ()
10377502

  • Glucose IVD, kit, spectrophotometry

ADVIA Centaur® aHBs2 - 00630414561790

Anti-HBs2 (aHBs2) Assay Kit (1-pack) 200T
Siemens Healthcare Diagnostics Inc.
10286268
In Commercial Distribution

  • 00630414561790 ()
4670661

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry TOB_2 Tobramycin_2 Reagents - 00630414561677

Tobramycin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10376932
In Commercial Distribution

  • 00630414561677 ()
10376932

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry CYSC Cystatin-C Calibrators - 00630414561578

Cystatin C - ADVIA Chem. - CAL - 5x2mL
Siemens Healthcare Diagnostics Inc.
10376487
Not in Commercial Distribution

  • 00630414561578 ()
10376487

  • Cystatin C IVD, calibrator

ADVIA® Chemistry Drug Calibrator II - 00630414561332

Drug 2 - ADVIA Chem. - CAL - 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10376771
In Commercial Distribution

  • 00630414561332 ()
10376771

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA® Chemistry Drug Calibrator I - 00630414561325

Drug 1 - ADVIA Chem. - CAL - 2x5x5mL
Siemens Healthcare Diagnostics Inc.
10376770
In Commercial Distribution

  • 00630414561325 ()
10376770

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent - 00630414561073

Cholesterol - ADVIA Chem. - RGT - 7x350/7x280 tests
Siemens Healthcare Diagnostics Inc.
10376501
In Commercial Distribution

  • 00630414561073 ()
  • 00630414003764 ()
10376501

  • Total cholesterol lipid IVD, kit, spectrophotometry

ADVIA® Chemistry CARB_2 Reagents - 00630414560793

Carbamazepine - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10376342
In Commercial Distribution

  • 00630414560793 ()
10376342

  • Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ADVIA Autoslide® Slide Maker Stainer - 00630414560595

ADVIA® Autoslide Slide Maker Stainer
Siemens Healthcare Diagnostics Inc.
10282177
In Commercial Distribution

  • 00630414560595 ()
085-A001-02

  • Microscope slide maker/stainer IVD

ADVIA® 2120i Hematology System - 00630414560045

ADVIA®2120i Hematology System
Siemens Healthcare Diagnostics Inc.
10285573
In Commercial Distribution

  • 00630414560045 ()
067-A013-01

  • Haematological cell analyser IVD

ADVIA Centaur® T3 MCM - 00630414559704

T3 Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10361928
In Commercial Distribution

  • 00630414559704 ()
4848169

  • Total triiodothyronine (TT3) IVD, control

ADVIA ® 120/2120/2120i EZ WASH - 00630414558400

ADVIA®120/2120/2120i EZ WASH
Siemens Healthcare Diagnostics Inc.
10285021
In Commercial Distribution

  • 00630414558400 ()
4871500

  • Wash/cleaning solution IVD, automated/semi-automated system

ADVIA® Chemistry LP(A) CALIBRATOR - 00630414558257

LP(A) - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285017
In Commercial Distribution

  • 00630414558257 ()
4865268

  • Lipoprotein A IVD, calibrator

ADVIA® Chemistry FRUC Calibrator - 00630414558240

Fructosamine - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285684
Not in Commercial Distribution

  • 00630414558240 ()
  • 00630414002996 ()
4865217

  • Fructosamine IVD, calibrator

ADVIA® Chemistry MYO CALIBRATOR - 00630414558233

Myoglobin Kit - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285682
Not in Commercial Distribution

  • 00630414558233 ()
4865160

  • Myoglobin IVD, calibrator

ADVIA® Chemistry B2M CAL Beta-2-Microglobulin Calibrator - 00630414558226

B2 Microglobulin - ADVIA Chem. - CAL - 3x1mL
Siemens Healthcare Diagnostics Inc.
10285680
Not in Commercial Distribution

  • 00630414558226 ()
  • 00630414002989 ()
4865101

  • Beta-2-microglobulin IVD, calibrator

ADVIA® Chemistry LP(A) Lipoprotein(a) Reagents - 00630414558080

Lipoprotein - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361942
In Commercial Distribution

  • 00630414558080 ()
4862528

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry FRUC Reagents - 00630414558073

Fructosamine - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361941
Not in Commercial Distribution

  • 00630414558073 ()
4862501

  • Fructosamine IVD, kit, spectrophotometry

ADVIA® Chemistry CYSC Cystatin-C Reagents - 00630414557915

Cystatin C - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10361930
Not in Commercial Distribution

  • 00630414557915 ()
4851534

  • Cystatin C IVD, kit, nephelometry/turbidimetry

ADVIA Centaur® SHBG Calibrator - 00630414556093

SHBG - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10285318
Not in Commercial Distribution

  • 00630414556093 ()
4819274

  • Sex hormone binding globulin (SHBG) IVD, calibrator

ADVIA® Chemistry CPC Calcium Reagents - 00630414555904

Calcium - ADVIA Chem. - RGT - 6x675 tests
Siemens Healthcare Diagnostics Inc.
10286036
In Commercial Distribution

  • 00630414555904 ()
4802312

  • Calcium (Ca2+) IVD, kit, spectrophotometry

ADVIA® Chemistry AMM Ammonia Reagents - 00630414555898

Ammonia - ADVIA Chem. - RGT - 2x138 tests
Siemens Healthcare Diagnostics Inc.
10286035
In Commercial Distribution

  • 00630414555898 ()
4802290

  • Ammonia IVD, kit, spectrophotometry

VERSANT® Sample Preparation 1.0 Reagents (Box 2) - 00630414555553

VERSANT® Sample Preparation 1.0 Reagents (Box 2)
Siemens Healthcare Diagnostics Inc.
10286027
In Commercial Distribution

  • 00630414555553 ()
4801685

  • Nucleic acid extraction/isolation kit IVD

VERSANT® Sample Preparation 1.0 Reagents (Box 1) - 00630414555546

VERSANT® Sample Preparation 1.0 Reagents (Box 1)
Siemens Healthcare Diagnostics Inc.
10286026
In Commercial Distribution

  • 00630414555546 ()
4801677

  • Nucleic acid extraction/isolation kit IVD

ADVIA Centaur® Calibrator A - 00630414555331

Thyroid (6PK) (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10285905
In Commercial Distribution

  • 00630414555331 ()
4800840

  • Multiple human hormone IVD, calibrator

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
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