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

  • 00630414121772 ()
570404

  • Phenytoin therapeutic drug monitoring IVD, calibrator
Phenytoin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311391
Not in Commercial Distribution

  • 00630414121765 ()
570403

  • Phenytoin therapeutic drug monitoring IVD, calibrator
Phenytoin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311390
Not in Commercial Distribution

  • 00630414121758 ()
570402

  • Phenytoin therapeutic drug monitoring IVD, control
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
Vancomycin - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10330624
Not in Commercial Distribution

  • 00630414121451 ()
570062

  • Vancomycin therapeutic drug monitoring IVD, calibrator
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 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)
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
100 blood collection capillary tubes. Each tube contains 130-200 units/mL Lithium Heparin (approx. volume 100µL)
Siemens Healthcare Diagnostics Inc.
10321712
In Commercial Distribution

  • 00630414115740 ()
  • 00630414009490 ()
478600

  • Capillary blood collection tube IVD, lithium heparin
Multicap® and Multicap-S 2.34mm OD blood collection capillary tubes
Siemens Healthcare Diagnostics Inc.
10328655
In Commercial Distribution

  • 00630414115238 ()
  • 00630414010502 ()
478527

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
Ready Sensor™ GOLD Replacement reference Sensor Inner Element. An in vitro diagnostics device.
Siemens Healthcare Diagnostics Inc.
10329947
In Commercial Distribution

  • 00630414115030 ()
478509

  • Ion selective electrode (ISE) reference solution IVD, reagent
RAPIDLab® 248 Wash Reagent for in vitro diagnostics use with the RAPIDLab® 248 analyzers.
Siemens Healthcare Diagnostics Inc.
10310997
In Commercial Distribution

  • 00630414106564 ()
  • 00630414010052 ()
473497

  • Wash/cleaning solution IVD, automated/semi-automated system
RAPIDLab® 248 6.8/7.3 Calibration buffer reagent is an in vitro diagnostics medical device for use with the RAPIDLab® 248 Blood gas analyzer.
Siemens Healthcare Diagnostics Inc.
10310996
In Commercial Distribution

  • 00630414106540 ()
473496

  • Multiple blood gas analyte IVD, calibrator
50 blood collection capillary tubes (approx. volume 140µL). For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb
Siemens Healthcare Diagnostics Inc.
10314796
In Commercial Distribution

  • 00630414105994 ()
  • 00630414010120 ()
473193

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
100 blood collection capillary tubes (approx. volume 100uL) Each tube contains 130-200 I.U./mL lithium heparin titrated with Na+/K+. For capillary blood collection for the analysis of pH/Blood Gas and Na+/K+ by ISE analyzer
Siemens Healthcare Diagnostics Inc.
10310990
In Commercial Distribution

  • 00630414099231 ()
  • 00630414009247 ()
471836

  • Capillary blood collection tube IVD, lithium heparin
RAPIDLyte Multicap blood collection capillary tubes (500 tubes) approx. volume 100µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10322912
In Commercial Distribution

  • 00630414058320 ()
  • 00630414009506 ()
108758

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
LH 2 Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10309794
In Commercial Distribution

  • 00630414057361 ()
106794

  • Luteinizing hormone (LH) IVD, control
ADVIA 2120I HEMATOLOGY SYSTEM (ROHS) WITH DUAL ASPIRATE
Siemens Healthcare Diagnostics Inc.
11219529
In Commercial Distribution

  • 00630414019772 ()
11219529

  • Haematological cell analyser IVD
Herpes-1 IgG (HSV1) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720847
In Commercial Distribution

  • 00630414016757 ()
10720847

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
Herpes-1 IgG (HSV1) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720846
In Commercial Distribution

  • 00630414016740 ()
10720846

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Herpes-2 IgG (HSV2) ADVIA Centaur - Quality Control
Siemens Healthcare Diagnostics Inc.
10720850
In Commercial Distribution

  • 00630414016733 ()
10720850

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
Herpes-2 IgG (HSV2) ADVIA Centaur - RGT – 100T
Siemens Healthcare Diagnostics Inc.
10720849
In Commercial Distribution

  • 00630414016726 ()
10720849

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
for in vitro diagnostic use for multi-level quality control of RAPIDPoint® 400 system only.
Siemens Healthcare Diagnostics Inc.
11046781
In Commercial Distribution

  • 00630414016627 ()
11046781

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Procalcitonin (PCT) Atellica IM - Master Curve Material 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998265
In Commercial Distribution

  • 00630414014197 ()
10998265

  • Procalcitonin (PCT) IVD, control
Dimension® EXL™ with LM Integrated Chemistry System with Reagent Management System (RMS) and Sample Transfer Module (STM)
Siemens Healthcare Diagnostics Inc.
10718149
In Commercial Distribution

  • 00630414014135 ()
759020.911

  • Multiple clinical chemistry analyser IVD, laboratory
Dimension® EXL™ with LM integrated chemistry system with Reagent Management System (RMS)
Siemens Healthcare Diagnostics Inc.
10475506
In Commercial Distribution

  • 00630414014128 ()
778020.911

  • Multiple clinical chemistry analyser IVD, laboratory
No Description
Siemens Healthcare Diagnostics Inc.
10995083
In Commercial Distribution

  • 00630414010472 ()
10995083

  • Interleukin-6 (IL-6) IVD, control
ADVIA Centaur ® IL-6 100T Kit
Siemens Healthcare Diagnostics Inc.
10995080
In Commercial Distribution

  • 00630414010434 ()
10995080

  • Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassay
Erythropoietin (EPO) QC Kit - ADVIA Centaur - CLT 3 x 3 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10995099
In Commercial Distribution

  • 00630414010403 ()
10995099

  • Erythropoietin (EPO) IVD, control
Erythropoietin (EPO) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1mL
Siemens Healthcare Diagnostics Inc.
10995098
In Commercial Distribution

  • 00630414010397 ()
10995098

  • Erythropoietin (EPO) IVD, control
Erythropoietin (EPO) - ADVIA Centaur - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995096
In Commercial Distribution

  • 00630414010380 ()
10995096

  • Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay
Calcitonin (CALCT) ADVIA Centaur - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995094
In Commercial Distribution

  • 00630414010373 ()
10995094

  • Calcitonin IVD, control
A1C Reagent Kit
Siemens Healthcare Diagnostics Inc.
10720885
In Commercial Distribution

  • 00630414006666 ()
K3105B

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
A1C Reagent Kit
Siemens Healthcare Diagnostics Inc.
10720883
In Commercial Distribution

  • 00630414006659 ()
DF105B

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Creatine Kinase Liquid (CK_L) Atellica CH - RGT 664T
Siemens Healthcare Diagnostics Inc.
11097640
In Commercial Distribution

  • 00630414006642 ()
11097640

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
ADVIA A1c_E Pretreatment Solution, 1L
Siemens Healthcare Diagnostics Inc.
10721048
In Commercial Distribution

  • 00630414002880 ()
10721048

  • Glycated haemoglobin (HbA1c) IVD, reagent
ADVIA A1c_E Calibrator, 1x 3mL
Siemens Healthcare Diagnostics Inc.
10720859
In Commercial Distribution

  • 00630414002873 ()
10720859

  • Glycated haemoglobin (HbA1c) IVD, calibrator
ADVIA A1c_E Reagent (Large Kit), 1200 tests
Siemens Healthcare Diagnostics Inc.
10720858
In Commercial Distribution

  • 00630414002866 ()
10720858

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry
ADVIA A1c_E Reagent (Small Kit), 300 tests
Siemens Healthcare Diagnostics Inc.
10720857
In Commercial Distribution

  • 00630414002859 ()
10720857

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry
Multi-drug QC (Urine) Atellica CH - CTL 3 x 5mL
Siemens Healthcare Diagnostics Inc.
11099406
Not in Commercial Distribution

  • 00630414002699 ()
  • 00630414211572 ()
11099406

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Atellica SAMPLE HANDLER ADDITIONAL MODULE
Siemens Healthcare Diagnostics Inc.
11069004
In Commercial Distribution

  • 00630414002460 ()
11069004

  • Specimen processing instrument IVD
Atellica SAMPLE HANDLER PRIMARY MODULE
Siemens Healthcare Diagnostics Inc.
11069001
In Commercial Distribution

  • 00630414002439 ()
11069001

  • Specimen processing instrument IVD
Atellica DL PRIMARY KIT
Siemens Healthcare Diagnostics Inc.
11068009
In Commercial Distribution

  • 00630414002354 ()
11068009

  • Specimen processing instrument IVD
Atellica DL MODULE
Siemens Healthcare Diagnostics Inc.
11068008
In Commercial Distribution

  • 00630414002347 ()
11068008

  • Specimen processing instrument IVD
Atellica CH 930 Analyzer
Siemens Healthcare Diagnostics Inc.
11067000
In Commercial Distribution

  • 00630414002163 ()
11067000

  • Multiple clinical chemistry analyser IVD, laboratory
Atellica IM 1600 Analyzer
Siemens Healthcare Diagnostics Inc.
11066000
In Commercial Distribution

  • 00630414002026 ()
11066000

  • Chemiluminescent immunoassay analyser IVD
Stride Device Manager Application software kit
Siemens Healthcare Diagnostics Inc.
10714617
In Commercial Distribution

  • 00630414001975 ()
10714617

  • Medical equipment clinical data interfacing software
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