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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C-Peptide (CpS) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11206249
In Commercial Distribution

  • 00630414293615 ()
11206249

  • C-peptide IVD, kit, chemiluminescent immunoassay
Cortisol - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206248
In Commercial Distribution

  • 00630414294155 ()
  • 00630414293608 ()
11206248

  • Total cortisol IVD, kit, chemiluminescent immunoassay
CKMB - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206247
In Commercial Distribution

  • 00630414294148 ()
  • 00630414293592 ()
11206247

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
CEA - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206246
In Commercial Distribution

  • 00630414294131 ()
  • 00630414293585 ()
11206246

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Calibrator E - Atellica IM - CAL (6PK) 6 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206245
In Commercial Distribution

  • 00630414294124 ()
  • 00630414293578 ()
11206245

  • Multiple steroid hormone IVD, calibrator
Calibrator C - Atellica IM - CAL (6PK) 6 x 2 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
11206243
In Commercial Distribution

  • 00630414294100 ()
  • 00630414293554 ()
11206243

  • Multiple anaemia-related analyte IVD, calibrator
Calibrator A - Atellica IM - CAL (6PK) 2 x 6 x 5.0 mL
Siemens Healthcare Diagnostics Inc.
11206241
In Commercial Distribution

  • 00630414294087 ()
  • 00630414293530 ()
11206241

  • Multiple human hormone IVD, calibrator
CA 125II Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206266
In Commercial Distribution

  • 00630414294278 ()
  • 00630414293493 ()
11206266

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
BR Calibrator - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11206237
In Commercial Distribution

  • 00630414294056 ()
  • 00630414293486 ()
11206237

  • Cancer antigen 27-29 (CA27-29) IVD, calibrator
BNP - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206235
In Commercial Distribution

  • 00630414294032 ()
  • 00630414293462 ()
11206235

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
Dimension/Vista Lipase Calibrator
Siemens Healthcare Diagnostics Inc.
11538127
In Commercial Distribution

  • 00630414292755 ()
DC56B

  • Lipase IVD, calibrator
Dimension Lipase (LIP) Flex reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
11538126
In Commercial Distribution

  • 00630414306247 ()
  • 00630414292748 ()
DF56A

  • Lipase IVD, kit, spectrophotometry
Lithium_2 (LITH_2) ADVIA Chemistry - RGT 200T
Siemens Healthcare Diagnostics Inc.
11532400
In Commercial Distribution

  • 00630414288178 ()
11532400

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
Lithium_2 (LITH_2) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11532401
In Commercial Distribution

  • 00630414287935 ()
11532401

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy
Lactate_2 (Lac_2) Atellica CH - RGT 380T
Siemens Healthcare Diagnostics Inc.
11532568
Not in Commercial Distribution

  • 00630414287270 ()
11532568

  • Lactate IVD, kit, spectrophotometry
Urine Oxycodone Screen Flex reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
11533384
In Commercial Distribution

  • 00630414295053 ()
  • 00630414287263 ()
K5098

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
Urine Oxycodone Screen Flex reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
11533385
In Commercial Distribution

  • 00630414295060 ()
  • 00630414287256 ()
DF98

  • Oxycodone IVD, kit, enzyme immunoassay (EIA)
Anti-Mullerian Hormone (AMH) - Atellica IM - Quality Control Kit - 3 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11205265
In Commercial Distribution

  • 00630414286921 ()
11205265

  • Anti-Mullerian hormone (AMH) IVD, control
Anti-Mullerian Hormone (AMH) - Centaur - Quality Control Kit - 3 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
11205264
In Commercial Distribution

  • 00630414286914 ()
11205264

  • Anti-Mullerian hormone (AMH) IVD, control
Zika Ab Atellica IM Quality Control Material Kit 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11204648
In Commercial Distribution

  • 00630414286860 ()
11204648

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
Zika Ab tellica IM Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
11204647
In Commercial Distribution

  • 00630414286853 ()
11204647

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Zika IgM Atellica IM Quality Control Material Kit 2 x 2 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11204646
In Commercial Distribution

  • 00630414286846 ()
11204646

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
Zika IgM Atellica IM Assay Kit 50T
Siemens Healthcare Diagnostics Inc.
11204645
In Commercial Distribution

  • 00630414286839 ()
11204645

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
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
Androstenedione (Andro) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
11200558
In Commercial Distribution

  • 00630414285566 ()
11200558

  • Androstenedione IVD, kit, chemiluminescent immunoassay
Androstenedione (Andro) Atellica IM - Master Curve Material 5x1x1.0mL
Siemens Healthcare Diagnostics Inc.
11200557
In Commercial Distribution

  • 00630414285559 ()
11200557

  • Androstenedione IVD, control
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
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
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
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
Calcitonin Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11420592
In Commercial Distribution

  • 00630414284743 ()
11420592

  • Calcitonin IVD, kit, chemiluminescent immunoassay
ADVIA Centaur Calcitonin (CALCT) 100T Kit
Siemens Healthcare Diagnostics Inc.
11420589
In Commercial Distribution

  • 00630414284736 ()
11420589

  • Calcitonin IVD, kit, chemiluminescent immunoassay
Atellica CH UCFP Reagent
Siemens Healthcare Diagnostics Inc.
11097543
In Commercial Distribution

  • 00630414285313 ()
  • 00630414279206 ()
11097543

  • Total protein IVD, kit, spectrophotometry
Atellica CH UCFP Calibrator
Siemens Healthcare Diagnostics Inc.
11099339
In Commercial Distribution

  • 00630414285320 ()
  • 00630414279190 ()
11099339

  • Total protein IVD, calibrator
ADVIA Chemistry UCFP Calibrator
Siemens Healthcare Diagnostics Inc.
11319152
In Commercial Distribution

  • 00630414279183 ()
11319152

  • Total protein IVD, calibrator
ADVIA Chemistry UCFP Reagent
Siemens Healthcare Diagnostics Inc.
11319151
In Commercial Distribution

  • 00630414285245 ()
  • 00630414279176 ()
11319151

  • Total protein IVD, kit, spectrophotometry
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 Kit
Siemens Healthcare Diagnostics Inc.
11203473
In Commercial Distribution

  • 00630414278742 ()
11203473

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
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
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
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
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
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
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
Procalcitonin (PCT) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11202699
In Commercial Distribution

  • 00630414246550 ()
11202699

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
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
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
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
Erythropoietin (EPO) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10733006
In Commercial Distribution

  • 00630414245775 ()
10733006

  • Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay
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
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