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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 VANC_2 Vancomycin_2 Reagents - 00630414561967

Vancomycin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377509
In Commercial Distribution

  • 00630414561967 ()
10377509

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

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

Dimension Vista® 500 - 00630414949581

DIMENSION® VISTA® 500 Instrument
Siemens Healthcare Diagnostics Inc.
10284473
In Commercial Distribution

  • 00630414949581 ()
1000036563

  • Multiple clinical chemistry analyser IVD, laboratory

Dimension Vista® 1500 Intelligent Lab System - 00630414949536

Dimension Vista® 1500 Intelligent Lab System
Siemens Healthcare Diagnostics Inc.
10459469
In Commercial Distribution

  • 00630414949536 ()
1000033793

  • Multiple clinical chemistry analyser IVD, laboratory

Dimension Vista® Testosterone Calibrator - 00630414948775

Testosterone Calibrator, 12 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL; 2D x 1.0 mL; 2E x 1.0 mL; 2F x 1.0 mL)
Siemens Healthcare Diagnostics Inc.
10712611
In Commercial Distribution

  • 00630414948775 ()
KC638

  • Total testosterone IVD, calibrator

Dimension Vista® PROG Calibrator - 00630414948768

Progesterone Calibrator, 10 (2A x 1.0 mL; 2B x 1.0 mL; 2C x 1.0 mL;2D x 1.0 mL; 2E x 1.0 mL)
Siemens Healthcare Diagnostics Inc.
10712610
In Commercial Distribution

  • 00630414948768 ()
KC637

  • Progesterone IVD, calibrator

Dimension Vista® CHEM 1 CAL - 00630414948508

Chemistry 1 Calibrator, 6 (3A x 2.3 mL; 3B x 2.3 mL)
Siemens Healthcare Diagnostics Inc.
10716281
Not in Commercial Distribution

  • 00630414948508 ()
KC110B

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension® CHEM I CAL - 00630414948492

Chemistry I Calibrator, 2x3x2mL
Siemens Healthcare Diagnostics Inc.
10716280
In Commercial Distribution

  • 00630414948492 ()
DC18C

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® Flex® reagent cartridge AMM - 00630414948102

Ammonia Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10711992
In Commercial Distribution

  • 00630414948102 ()
  • 00630414006093 ()
K3119

  • Ammonia IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge AMM - 00630414948096

Ammonia Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10711991
In Commercial Distribution

  • 00630414948096 ()
  • 00630414006086 ()
DF119

  • Ammonia IVD, kit, spectrophotometry

Dimension® CHEM III CAL - 00630414948034

Chemistry III Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10711580
In Commercial Distribution

  • 00630414948034 ()
DC130

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® CHEM 3 CAL - 00630414948027

Chemistry 3 Calibrator, 6 (3A x 2.5 mL; 3B x 2.5 mL)
Siemens Healthcare Diagnostics Inc.
10711579
In Commercial Distribution

  • 00630414948027 ()
KC130A

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

RAPIDPoint® 500 Measurement Cartridge - 00630414947556

RAPIDPoint® 500 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Lac, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 500 analyzer.
Siemens Healthcare Diagnostics Inc.
10844813
In Commercial Distribution

  • 00630414947556 ()
10844813

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

RAPIDPoint® 405/500 Measurement Cartridge - 00630414947549

RAPIDPoint® 405/500 Measurement Cartridge (100 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.
10844812
In Commercial Distribution

  • 00630414947549 ()
10844812

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

RAPIDPoint® 405/500 Measurement Cartridge - 00630414947532

RAPIDPoint® 405/500 Measurement Cartridge (100 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.
10844811
In Commercial Distribution

  • 00630414947532 ()
10844811

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

RAPIDPoint® 400 Measurement Cartridge - 00630414947525

RAPIDPoint® 400 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 400 analyzer.
Siemens Healthcare Diagnostics Inc.
10844810
In Commercial Distribution

  • 00630414947525 ()
10844810

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

IMMULITE® 1000 Immunoassay System - 00630414947440

IMMULITE® 1000 Instrument, 110 VOLT
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10380058
In Commercial Distribution

  • 00630414947440 ()
030006-03

  • Chemiluminescent immunoassay analyser IVD

ADVIA® Chemistry Albumin BCP Calibrator - 00630414947426

ALBP KIT - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10711842
In Commercial Distribution

  • 00630414947426 ()
  • 00630414006079 ()
10711842

  • Albumin IVD, calibrator

ADVIA® Chemistry Albumin BCP Reagents - 00630414947419

Albumin - ADVIA Chem. - RGT - 4x1525
Siemens Healthcare Diagnostics Inc.
10711841
In Commercial Distribution

  • 00630414947419 ()
  • 00630414006055 ()
10711841

  • Albumin IVD, kit, spectrophotometry

ADVIA® Chemistry Albumin BCP Reagents - 00630414947402

Albumin - ADVIA Chem. - RGT - 4x800
Siemens Healthcare Diagnostics Inc.
10711840
In Commercial Distribution

  • 00630414947402 ()
  • 00630414006031 ()
10711840

  • Albumin IVD, kit, spectrophotometry

IMMULITE® 2000 XPi Immunoassay System - 00630414945422

IMMULITE® 2000 XPi Instrument
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10373214
In Commercial Distribution

  • 00630414945422 ()
030002-33

  • Chemiluminescent immunoassay analyser IVD

Atellica IM DHEAS2 (REF) 500T - 00630414652597

Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT)
Siemens Healthcare Diagnostics Inc.
11700159
In Commercial Distribution

  • 00630414321486 ()
  • 00630414652597 ()
11700159

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

Atellica IM 1600 Analyzer - 00630414650623

Atellica IM 1600 Analyzer (Refurbished)
Siemens Healthcare Diagnostics Inc.
11764888
In Commercial Distribution

  • 00630414650623 ()
11066000

  • Chemiluminescent immunoassay analyser IVD

Atellica IM 1300 Analyzer - 00630414650579

Atellica IM 1300 Analyzer (Refurbished)
Siemens Healthcare Diagnostics Inc.
11764765
In Commercial Distribution

  • 00630414650579 ()
11066001

  • Chemiluminescent immunoassay analyser IVD
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