SEARCH RESULTS FOR: siemens(7279 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 Centaur® Calibrator D - 00630414124797

Calibrator D - 2 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311569
In Commercial Distribution

  • 00630414124797 ()
672173000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator

ADVIA Centaur® Calibrator C - 00630414124780

Ferritin/VitB12 - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10311568
In Commercial Distribution

  • 00630414124780 ()
672172000

  • Multiple anaemia-related analyte IVD, calibrator

ADVIA Centaur Cortisol Urine Reconstitution Buffer - 00630414121819

Cortisol Urin - CENTAUR - CTL - 1x50mL
Siemens Healthcare Diagnostics Inc.
10318246
In Commercial Distribution

  • 00630414121819 ()
570408

  • Total cortisol IVD, reagent

CVM® Hct Calibration Verification Material for Hematocrit Systems - 00630414121802

Calibration Verification Material for Hematocrit (CVM® Hct) is a unique material formulated to verify the calibration of conductivity-based hematocrit test systems.
Siemens Healthcare Diagnostics Inc.
10330034
In Commercial Distribution

  • 00630414121802 ()
570407

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

RAPIDQC® Hct Level B - 00630414121796

For in vitro diagnostic use for quality control of Hematocrit Analyzers.
Siemens Healthcare Diagnostics Inc.
10311393
In Commercial Distribution

  • 00630414121796 ()
  • 00630414009346 ()
570406

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

RAPIDQC® Hct Level A - 00630414121789

For in vitro diagnostic use for quality control of Hematocrit Analyzers.
Siemens Healthcare Diagnostics Inc.
10311392
In Commercial Distribution

  • 00630414121789 ()
  • 00630414009339 ()
570405

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

ADVIA Centaur® PHTN Calibrator - 00630414121772

Phenytoin - CENTAUR - CAL - 6x6x5mL
Siemens Healthcare Diagnostics Inc.
10314977
Not in Commercial Distribution

  • 00630414121772 ()
570404

  • Phenytoin therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems PHTN Calibrator - 00630414121765

Phenytoin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311391
Not in Commercial Distribution

  • 00630414121765 ()
570403

  • Phenytoin therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® PHTN MCM - 00630414121758

Phenytoin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311390
Not in Commercial Distribution

  • 00630414121758 ()
570402

  • Phenytoin therapeutic drug monitoring IVD, control

RAPIDLab® High G/L - 00630414121628

For in vitro diagnostic use for verifying glucose and lactate sensor performance on the RAPIDLab® 1260 & 1265 systems
Siemens Healthcare Diagnostics Inc.
10311387
In Commercial Distribution

  • 00630414121628 ()
  • 00630414024516 ()
570097

  • Multiple blood gas analyte IVD, calibrator

ADVIA Centaur® Vancomycin Calibrator - 00630414121451

Vancomycin - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10330624
Not in Commercial Distribution

  • 00630414121451 ()
570062

  • Vancomycin therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® Systems, ACS:180® Systems VANC Calibrator - 00630414121444

Vancomycin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311377
Not in Commercial Distribution

  • 00630414121444 ()
570061

  • Vancomycin therapeutic drug monitoring IVD, calibrator

Ready Sensor™ Glucose Biosensor - 00630414121154

Ready Sensor™ Glucose Biosensor for use on the Siemens Healthcare Diagnostics RAPIDLab® Series systems - Single Glucose WarrantyReaplacement
Siemens Healthcare Diagnostics Inc.
10312818
In Commercial Distribution

  • 00630414121154 ()
570024

  • Glucose IVD, kit, ion-selective electrode (ISE)

RAPIDQC® Plus Level 3 - 00630414118444

For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Siemens Healthcare Diagnostics Inc.
10325104
In Commercial Distribution

  • 00630414118444 ()
  • 00630414009568 ()
478943000

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

RAPIDQC® Plus Level 2 - 00630414118413

For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Siemens Healthcare Diagnostics Inc.
10341140
In Commercial Distribution

  • 00630414118413 ()
  • 00630414009742 ()
478942000

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

RAPIDQC® Plus Level 1 - 00630414118383

For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Siemens Healthcare Diagnostics Inc.
10323692
In Commercial Distribution

  • 00630414118383 ()
  • 00630414009537 ()
478941000

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

RAPIDLab® Reference Electrode Fill - 00630414117539

RAPIDLab® series Reference Electrode Fill Solution. An in vitro diagnostic medical device for use with RAPIDLab® series analyzers.
Siemens Healthcare Diagnostics Inc.
10311081
In Commercial Distribution

  • 00630414117539 ()
  • 00630414010090 ()
478822

  • Ion selective electrode (ISE) reference solution IVD, reagent

Adapters - 00630414116297

100 Adaptors for an In vitro diagnostics device. For use with Siemens Healthcare Diagnostics blood collection capillary tubes and analyzers.
Siemens Healthcare Diagnostics Inc.
10330785
In Commercial Distribution

  • 00630414116297 ()
  • 00630414010168 ()
478647

  • Capillary blood collection tube IVD, electrolyte-balanced heparin

ADVIA® Chemistry FRT Ferritin Reagents - 00630414586069

Ferritin - ADVIA Chem. - RGT - 4x800 tests
Siemens Healthcare Diagnostics Inc.
10494078
In Commercial Distribution

  • 00630414586069 ()
10494078

  • Ferritin IVD, kit, nephelometry/turbidimetry

ADVIA Centaur® iPTH - 00630414585352

PTH intact - CENTAUR - RGT - 500 tests (REF)
Siemens Healthcare Diagnostics Inc.
10493616
In Commercial Distribution

  • 00630414585352 ()
10493616

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems VitD Calibrator - 00630414585093

Vitamin D - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10493589
In Commercial Distribution

  • 00630414585093 ()
10493589

  • Multiple form 25-hydroxy Vitamin D IVD, calibrator

ADVIA® Chemistry XTC Ecstasy Reagents - 00630414569857

Ecstasy - ADVIA Chem. - RGT - 4x190 tests
Siemens Healthcare Diagnostics Inc.
10378735
Not in Commercial Distribution

  • 00630414569857 ()
10378735

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents - 00630414569277

Ethanol - ADVIA Chem. - RGT - 4x150 tests
Siemens Healthcare Diagnostics Inc.
10379635
In Commercial Distribution

  • 00630414569277 ()
10379635

  • Ethanol (ETOH) IVD, kit, spectrophotometry

RAPIDPOINT® 340 Sampler Module - 00630414568584

RAPIDPOINT® 340 Sampler Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 340 analyzer
Siemens Healthcare Diagnostics Inc.
10375808
In Commercial Distribution

  • 00630414568584 ()
10375808

  • Blood gas/haemoximetry analyser IVD, point-of-care

RAPIDPOINT® 340/350 pO2 Electrode - 00630414566269

RAPIDPOINT® 340/350 pO2 Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375798
In Commercial Distribution

  • 00630414566269 ()
10375798

  • Blood oxygen electrode IVD

RAPIDPOINT®340/350 pH Electrode - 00630414566245

RAPIDPOINT® 340/350 pH Electrode for use with Rapidpoint® 340/350 Analyzers.
Siemens Healthcare Diagnostics Inc.
10375796
In Commercial Distribution

  • 00630414566245 ()
10375796

  • Blood pH electrode

ADVIA(R) 2120i Hematology System - 00630414565583

TBD
Siemens Healthcare Diagnostics Inc.
10361793
In Commercial Distribution

  • 00630414565583 ()
067-A020-03

  • Haematological cell analyser IVD

ADVIA® Chemistry IRON_2 Iron 2 Reagents - 00630414561974

Iron - ADVIA Chem. - RGT - 6x350 tests
Siemens Healthcare Diagnostics Inc.
10377510
In Commercial Distribution

  • 00630414561974 ()
10377510

  • Iron IVD, kit, spectrophotometry

ADVIA® Chemistry VANC_2 Vancomycin_2 Reagents - 00630414561967

Vancomycin - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10377509
Not in Commercial Distribution

  • 00630414561967 ()
10377509

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

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® 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 MYO CALIBRATOR - 00630414558233

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

  • 00630414558233 ()
4865160

  • Myoglobin IVD, calibrator

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 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
Not 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
Not 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
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