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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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RAPIDPoint® 500e Blood Gas System - 00630414286143

The RAPIDPoint® 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and issuitable for professional use in a point-of-care or central laboratory environment. This system measures the following: blood gases,electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.Additionally, the RAPIDPoint 500e Blood Gas System measures pH in pleural fluid.
Siemens Healthcare Diagnostics Inc.
11416751
In Commercial Distribution

  • 00630414286143 ()
11416751

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

Atellica IM Androstenedione kit - 00630414285566

Androstenedione (Andro) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11200558
In Commercial Distribution

  • 00630414285566 ()
11200558

  • Androstenedione IVD, kit, chemiluminescent immunoassay

Atellica IM PBNPII - 00630414284958

NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11203762
In Commercial Distribution

  • 00630414284958 ()
11203762

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Atellica IM PBNPII - 00630414284941

NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11203761
In Commercial Distribution

  • 00630414284941 ()
11203761

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

ADVIA Centaur PBNPII - 00630414284934

NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11203760
In Commercial Distribution

  • 00630414284934 ()
11203760

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

ADVIA Centaur PBNPII - 00630414284927

NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11203759
In Commercial Distribution

  • 00630414284927 ()
11203759

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Atellica IM Calcitonin - 00630414284743

Calcitonin Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11420592
In Commercial Distribution

  • 00630414284743 ()
11420592

  • Calcitonin IVD, kit, chemiluminescent immunoassay

ADVIA Centaur Calcitonin - 00630414284736

ADVIA Centaur Calcitonin (CALCT) 100T Kit
Siemens Healthcare Diagnostics Inc.
11420589
In Commercial Distribution

  • 00630414284736 ()
11420589

  • Calcitonin IVD, kit, chemiluminescent immunoassay

Atellica CH UCFP - 00630414279206

Atellica CH UCFP Reagent
Siemens Healthcare Diagnostics Inc.
11097543
In Commercial Distribution

  • 00630414285313 ()
  • 00630414279206 ()
11097543

  • Total protein IVD, kit, spectrophotometry

Atellica CH UCFP Calibrator - 00630414279190

Atellica CH UCFP Calibrator
Siemens Healthcare Diagnostics Inc.
11099339
In Commercial Distribution

  • 00630414285320 ()
  • 00630414279190 ()
11099339

  • Total protein IVD, calibrator

ADVIA Chemistry UCFP Calibrator - 00630414279183

ADVIA Chemistry UCFP Calibrator
Siemens Healthcare Diagnostics Inc.
11319152
In Commercial Distribution

  • 00630414279183 ()
11319152

  • Total protein IVD, calibrator

ADVIA Chemistry UCFP - 00630414279176

ADVIA Chemistry UCFP Reagent
Siemens Healthcare Diagnostics Inc.
11319151
In Commercial Distribution

  • 00630414285245 ()
  • 00630414279176 ()
11319151

  • Total protein IVD, kit, spectrophotometry

ADVIA Centaur HCV - 00630414278759

ADVIA Centaur HCV 200T Kit
Siemens Healthcare Diagnostics Inc.
11203483
In Commercial Distribution

  • 00630414278759 ()
11203483

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

Atellica IM aHCV 200T - 00630414278742

Atellica IM aHCV 200T Kit
Siemens Healthcare Diagnostics Inc.
11203473
In Commercial Distribution

  • 00630414278742 ()
11203473

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay

ADVIA Centaur Zika Ab QC - 00630414247038

Zika Ab ADVIA Centaur Quality Control Material Kit 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11202474
In Commercial Distribution

  • 00630414247038 ()
11202474

  • Zika virus immunoglobulin M (IgM) antibody IVD, control

ADVIA Centaur Zika Ab 100T - 00630414247021

Zika Ab ADVIA Centaur Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
11202473
In Commercial Distribution

  • 00630414247021 ()
11202473

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur Zika IgM QC - 00630414247014

Zika IgM ADVIA Centaur Quality Control Material Kit 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11202472
In Commercial Distribution

  • 00630414247014 ()
11202472

  • Zika virus immunoglobulin M (IgM) antibody IVD, control

ADVIA Centaur Zika IgM 50T - 00630414247007

Zika IgM ADVIA Centaur Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11202471
In Commercial Distribution

  • 00630414247007 ()
11202471

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Atellica IM CMV IgG - 00630414246635

CMV IgG Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202208
In Commercial Distribution

  • 00630414246635 ()
11202208

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Atellica IM BRAHMS PCT QC Kit - 00630414246567

Procalcitonin (PCT) QC Kit Atellica IM - CLT 2 x 2 x 2.0mL/vial
Siemens Healthcare Diagnostics Inc.
11202700
In Commercial Distribution

  • 00630414246567 ()
  • 00630414246581 ()
11202700

  • Procalcitonin (PCT) IVD, control

Atellica IM BRAHMS PCT - 00630414246550

Procalcitonin (PCT) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11202699
In Commercial Distribution

  • 00630414246550 ()
11202699

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay

Atellica IM CMV IgG Quality Control - 00630414246482

CMV IgG Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
11202209
In Commercial Distribution

  • 00630414246482 ()
  • 00630414283920 ()
11202209

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

Atellica IM EPO QC - 00630414245799

Erythropoietin (EPO) QC Kit - Atellica IM - CLT 3 x 3 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10733008
In Commercial Distribution

  • 00630414245799 ()
10733008

  • Erythropoietin (EPO) IVD, control

Atellica IM EPO MCM - 00630414245782

Erythropoietin (EPO) - Atellica IM - Master Curve Material Kit 5 x 1 x 1mL
Siemens Healthcare Diagnostics Inc.
10733007
In Commercial Distribution

  • 00630414245782 ()
10733007

  • Erythropoietin (EPO) IVD, control

Atellica IM EPO - 00630414245775

Erythropoietin (EPO) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10733006
In Commercial Distribution

  • 00630414245775 ()
10733006

  • Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay

Atellica IM Calcitonin MCM - 00630414245768

Calcitonin (CALCT) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10733005
In Commercial Distribution

  • 00630414245768 ()
10733005

  • Calcitonin IVD, control

Atellica IM AB12 MCM - 00630414245744

Active-B12 (AB12) Atellica IM - Master Curve Material Kit 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10733003
In Commercial Distribution

  • 00630414245744 ()
10733003

  • Holotranscobalamin (holoTC) IVD, control

Atellica IM AB12 QC - 00630414245737

Active-B12 (AB12) QC Kit Atellica IM - CLT 2 x 1 x 7.0mL
Siemens Healthcare Diagnostics Inc.
10733002
In Commercial Distribution

  • 00630414245737 ()
10733002

  • Holotranscobalamin (holoTC) IVD, control

Atellica IM AB12 - 00630414245720

Active-B12 (AB12) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10733001
In Commercial Distribution

  • 00630414245720 ()
10733001

  • Holotranscobalamin (holoTC) IVD, kit, chemiluminescent immunoassay

Atellica IM aCCP MCM - 00630414245683

anti-CCP IgG (aCCP) Atellica IM - Master Curve Material 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10733000
In Commercial Distribution

  • 00630414245683 ()
10733000

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

Atellica IM aCCP QC - 00630414245676

anti-CCP IgG (aCCP) QC Kit Atellica IM - CLT 2 x 1 x 7.0 mL
Siemens Healthcare Diagnostics Inc.
10732999
In Commercial Distribution

  • 00630414245676 ()
10732999

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

Atellica IM aCCP - 00630414245669

anti-CCP IgG (aCCP) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10732998
In Commercial Distribution

  • 00630414245669 ()
10732998

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay

Dimension Vista T4/TU CAL - 00630414240268

Vista T4/TU CAL
Siemens Healthcare Diagnostics Inc.
11319105
In Commercial Distribution

  • 00630414240268 ()
KC165

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Atellica IM AFP - 00630414238807

Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 500T
Siemens Healthcare Diagnostics Inc.
11202258
In Commercial Distribution

  • 00630414238807 ()
11202258

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Atellica IM AFP - 00630414238791

Alpha-Fetoprotein(AFP) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11202257
In Commercial Distribution

  • 00630414238791 ()
11202257

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

DM EXL LOCI BRAHMS PCT Cal Kit - 00630414238708

Procalcitonin (PCT) DM EXL LOCI BRAHMS - Cal Kit
Siemens Healthcare Diagnostics Inc.
11354448
In Commercial Distribution

  • 00630414295039 ()
  • 00630414238708 ()
RC648

  • Procalcitonin (PCT) IVD, calibrator

DM EXL LOCI BRAHMS PCT - 00630414238692

Procalcitonin (PCT) DM EXL LOCI BRAHMS - RGT
Siemens Healthcare Diagnostics Inc.
11354447
In Commercial Distribution

  • 00630414298214 ()
  • 00630414238692 ()
RF648

  • Procalcitonin (PCT) IVD, reagent

Atellica CH AMY_2 - 00630414238357

Amylase_2 (AMY_2) Atellica CH - RGT 1050T
Siemens Healthcare Diagnostics Inc.
11097649
In Commercial Distribution

  • 00630414238357 ()
11097649

  • Total amylase IVD, kit, spectrophotometry

Atellica CH TACR - 00630414238340

Tacrolimus (TACR) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097542
In Commercial Distribution

  • 00630414238340 ()
11097542

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

POCcelerator™ SE Data Management System - 00630414238142

No Description
Siemens Healthcare Diagnostics Inc.
10736583
In Commercial Distribution

  • 00630414238142 ()
10736583

  • Medical equipment clinical data interfacing software

Atellica CH CYSC_2 Calibrators - 00630414238104

Cystatin C_2 (CYSC_2) Calibrators Atellica CH - CAL 5 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11097648
In Commercial Distribution

  • 00630414238104 ()
11097648

  • Cystatin C IVD, calibrator

Atellica CH OXY - 00630414238098

Oxycodone (OXY) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097541
In Commercial Distribution

  • 00630414238098 ()
11097541

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)

ADVIA 2120i Refurb w/o Autosampler - 00630414237909

ADVIA 2120i Refurbished System, Without Autosampler
Siemens Healthcare Diagnostics Inc.
11314046
In Commercial Distribution

  • 00630414237909 ()
11314046

  • Haematological cell analyser IVD

ADVIA 2120i Refurbished System Dual Aspirate - 00630414237886

ADVIA 2120i Refurbished System, Dual Aspirate
Siemens Healthcare Diagnostics Inc.
11314045
In Commercial Distribution

  • 00630414237886 ()
11314045

  • Haematological cell analyser IVD

C-SAA ANALYT MODULE ASSY 2120I - 00630414237879

ADVIA 2120i Refurbished System, Single Aspirate
Siemens Healthcare Diagnostics Inc.
11314044
In Commercial Distribution

  • 00630414237879 ()
11314044

  • Haematological cell analyser IVD

Atellica Multi-Diluent 15 - 00630414237701

Atellica IM Multi-Diluent 15
Siemens Healthcare Diagnostics Inc.
11200798
In Commercial Distribution

  • 00630414246826 ()
  • 00630414237701 ()
11200798

  • Buffered sample diluent IVD

Atellica CH CYSC_2 - 00630414236919

Cystatin C_2 (CYSC_2) Atellica CH - RGT 800T
Siemens Healthcare Diagnostics Inc.
11097647
In Commercial Distribution

  • 00630414236919 ()
11097647

  • Cystatin C IVD, kit, nephelometry/turbidimetry

ADVIA Centaur® TSTO - 00630414235271

ADVIA Centaur® Testosterone (TSTO) Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11201912
Not in Commercial Distribution

  • 00630414235271 ()
11201912

  • Total testosterone IVD, kit, chemiluminescent immunoassay

Dimension Vista ECREA CAL - 00630414235103

Dimension Vista ECREA CAL
Siemens Healthcare Diagnostics Inc.
11349584
In Commercial Distribution

  • 00630414235103 ()
KC270A

  • Creatinine IVD, calibrator

Dimension Vista CHEM 1 CAL - 00630414235097

Dimension Vista CHEM 1 CAL
Siemens Healthcare Diagnostics Inc.
11349583
In Commercial Distribution

  • 00630414235097 ()
KC110C

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
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