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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IgE - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10309986
In Commercial Distribution

  • 00630414177489 ()
  • 00630414003269 ()
110778

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
IgE - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309985
In Commercial Distribution

  • 00630414177472 ()
110777

  • Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay
CKMB Mass - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10326496
In Commercial Distribution

  • 00630414177441 ()
  • 00630414003627 ()
110774

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
CKMB Mass - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309982
In Commercial Distribution

  • 00630414177434 ()
110773

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay
Digoxin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10322129
In Commercial Distribution

  • 00630414177427 ()
  • 00630414003566 ()
110772

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
Digoxin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309981
In Commercial Distribution

  • 00630414177410 ()
110771

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
Alpha-Fetoprotein (AFP) Assay Kit (5-pack) 500T
Siemens Healthcare Diagnostics Inc.
10309980
In Commercial Distribution

  • 00630414177335 ()
  • 00630414601724 ()
110764

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Alpha-Fetoprotein (AFP) Assay Kit (1-pack) 100T
Siemens Healthcare Diagnostics Inc.
10309979
In Commercial Distribution

  • 00630414177328 ()
110763

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
CEA - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10309978
In Commercial Distribution

  • 00630414177311 ()
  • 00630414003252 ()
110762

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
CEA - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309977
In Commercial Distribution

  • 00630414177304 ()
110761

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Prolactin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10309976
In Commercial Distribution

  • 00630414177274 ()
  • 00630414003245 ()
110758

  • Prolactin IVD, kit, chemiluminescent immunoassay
Prolactin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309975
In Commercial Distribution

  • 00630414177267 ()
110757

  • Prolactin IVD, kit, chemiluminescent immunoassay
FSH - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10309974
In Commercial Distribution

  • 00630414177250 ()
  • 00630414003238 ()
110756

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
FSH - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309973
In Commercial Distribution

  • 00630414177243 ()
110755

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
LH - CENTAUR - RGT - 300 tests
Siemens Healthcare Diagnostics Inc.
10309972
In Commercial Distribution

  • 00630414177236 ()
  • 00630414003221 ()
110754

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
LH - CENTAUR - RGT - 60 tests
Siemens Healthcare Diagnostics Inc.
10309971
In Commercial Distribution

  • 00630414177229 ()
110753

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Vitamin B12 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10330218
In Commercial Distribution

  • 00630414177175 ()
  • 00630414003665 ()
110748

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Vitamin B12 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309970
In Commercial Distribution

  • 00630414177168 ()
110747

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Ferritin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10309969
In Commercial Distribution

  • 00630414177151 ()
  • 00630414003214 ()
110746

  • Ferritin IVD, kit, chemiluminescent immunoassay
Ferritin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309968
In Commercial Distribution

  • 00630414177144 ()
110745

  • Ferritin IVD, kit, chemiluminescent immunoassay
T Uptake - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10309967
In Commercial Distribution

  • 00630414177137 ()
  • 00630414003207 ()
110744

  • Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay
T Uptake - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10309966
In Commercial Distribution

  • 00630414177120 ()
110743

  • Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay
T4 Total - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10309961
In Commercial Distribution

  • 00630414177052 ()
  • 00630414003191 ()
110736

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
T4 Total - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309960
In Commercial Distribution

  • 00630414177045 ()
110735

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
TSH - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10309959
In Commercial Distribution

  • 00630414177038 ()
110734

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10309958
In Commercial Distribution

  • 00630414177021 ()
110732

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
T3/T4/Vit-B12 ANC Reagent - CENTAUR - CAL - 6x25mL
Siemens Healthcare Diagnostics Inc.
10309954
In Commercial Distribution

  • 00630414175386 ()
  • 00630414003184 ()
110329

  • Multiple thyroid marker IVD, reagent
T3/T4/Vit.B12 ANC Reagent - CENTAUR - CAL - 2x25mL
Siemens Healthcare Diagnostics Inc.
10319315
In Commercial Distribution

  • 00630414175379 ()
  • 00630414003542 ()
110328

  • Multiple thyroid marker IVD, reagent
IgE Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309952
In Commercial Distribution

  • 00630414175331 ()
  • 00630414003177 ()
110324

  • Buffered sample diluent IVD
CKMB Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309951
In Commercial Distribution

  • 00630414175324 ()
  • 00630414003160 ()
110323

  • Buffered sample diluent IVD
CEA Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309950
In Commercial Distribution

  • 00630414175317 ()
  • 00630414003153 ()
110322

  • Buffered sample diluent IVD
VitaminB 12 Dil.RP (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309949
In Commercial Distribution

  • 00630414175300 ()
  • 00630414003146 ()
110321

  • Buffered sample diluent IVD
Multidil 7 (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309947
Not in Commercial Distribution

  • 00630414175270 ()
  • 00630414003139 ()
110318

  • Buffered sample diluent IVD
Multidil 5Readypack (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309946
Not in Commercial Distribution

  • 00630414175263 ()
  • 00630414003122 ()
110317

  • Buffered sample diluent IVD
Multidil 4 (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309945
In Commercial Distribution

  • 00630414175256 ()
  • 00630414003115 ()
110316

  • Buffered sample diluent IVD
Multidil3Readypack (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309944
In Commercial Distribution

  • 00630414175249 ()
  • 00630414003108 ()
110315

  • Buffered sample diluent IVD
Multidil 2 Readypack (2PK) - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10309943
In Commercial Distribution

  • 00630414175232 ()
  • 00630414003092 ()
110314

  • Buffered sample diluent IVD
Multidil 1 (6PK) - CENTAUR - CAL - 6x25mL
Siemens Healthcare Diagnostics Inc.
10309942
In Commercial Distribution

  • 00630414175225 ()
  • 00630414003085 ()
110313

  • Buffered sample diluent IVD
Multidil 1 Readypack(2PK) - CENTAUR - CAL - 2x25mL
Siemens Healthcare Diagnostics Inc.
10309941
In Commercial Distribution

  • 00630414175218 ()
  • 00630414003078 ()
110312

  • Buffered sample diluent IVD
A blood collection tube holder; to be used with DCA® Systems HbA1c Reagent Cartridge.
Siemens Healthcare Diagnostics Inc.
10888741
In Commercial Distribution

  • 00630414171142 ()
  • 00630414211039 ()
10888741

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
ADVIA Centaur® Zika IgM Controls
Siemens Healthcare Diagnostics Inc.
11200111
Not in Commercial Distribution

  • 00630414170886 ()
11200111

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
ADVIA Centaur® Zika IgM Assay
Siemens Healthcare Diagnostics Inc.
11200103
Not in Commercial Distribution

  • 00630414170862 ()
11200103

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
The Xprecia™ System PT Controls; For use with Xprecia System, supplying assayed controls for prothrombin time (PT).
Siemens Healthcare Diagnostics Inc.
10873633
In Commercial Distribution

  • 00630414170794 ()
10873633

  • Prothrombin time (PT) IVD, control
ADVIA Chemistry Systems 70-mL Wedges –Yellow
Siemens Healthcare Diagnostics Inc.
11223140
In Commercial Distribution

  • 00630414168258 ()
11223140

  • Assay container IVD, single-use
Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit
Siemens Healthcare Diagnostics Inc.
10720832
In Commercial Distribution

  • 00630414167947 ()
10720832

  • Hepatitis B virus e-antigen total antibody IVD, control
Anti-HBe2 (aHBe2) – ADVIA Centaur – RGT 50T
Siemens Healthcare Diagnostics Inc.
10720831
In Commercial Distribution

  • 00630414167923 ()
10720831

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
Blank sensor to replace the K+/Ca++/Cl-sensor. An in vitro medical device used on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10311665
In Commercial Distribution

  • 00630414132075 ()
673702

  • Blood gas/haemoximetry analyser IVD, point-of-care
Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10326708
In Commercial Distribution

  • 00630414132051 ()
673701000

  • Lactate electrode IVD
Reference Test/Blank sensor, an in vitro diagnostics device to replace the Reference sensor on the RAPIDLab® 248/348/348ex analyzers
Siemens Healthcare Diagnostics Inc.
10327492
In Commercial Distribution

  • 00630414132013 ()
673396000

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDLyte Multicap blood collection capillary tubes (50 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.
10323539
In Commercial Distribution

  • 00630414131986 ()
  • 00630414009520 ()
673394

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
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