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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Enzymatic Hemoglobin A1c (A1c_E) Calibrator Atellica CH - CAL 1 x 5.0 mL, 2 x 2 x 1.0 mL
Siemens Healthcare Diagnostics Inc.
11099338
In Commercial Distribution

  • 00630414220512 ()
11099338

  • Glycated haemoglobin (HbA1c) IVD, calibrator
Cuvette wash solution - ADVIA Chem. - CONS - 1x2000mL
Siemens Healthcare Diagnostics Inc.
10311853
In Commercial Distribution

  • 00630414210001 ()
B01-4178-51

  • Buffered wash solution IVD
ISE Buffer - ADVIA Chem. - CONS - 2 Liter
Siemens Healthcare Diagnostics Inc.
10311849
In Commercial Distribution

  • 00630414209968 ()
B01-4171-51

  • pH-adjusted buffer solution IVD
GGT - ADVIA Chem. - RGT - 4x675 tests
Siemens Healthcare Diagnostics Inc.
10316298
In Commercial Distribution

  • 00630414209753 ()
B01-4138-01

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
Triglyceride - ADVIA Chem. - RGT - 4x575/4x450 tests
Siemens Healthcare Diagnostics Inc.
10311837
Not in Commercial Distribution

  • 00630414209708 ()
  • 00630414003399 ()
B01-4133-01

  • Triglyceride IVD, kit, spectrophotometry
ADVIA Centaur® FER (5-pack)
Siemens Healthcare Diagnostics Inc.
10340414
In Commercial Distribution

  • 00630414204703 ()
  • 00630414010625 ()
118815

  • Ferritin IVD, kit, chemiluminescent immunoassay
Lutenizing Hormone (Ref) - CENTAUR - RGT - 300 tests
Siemens Healthcare Diagnostics Inc.
10332181
In Commercial Distribution

  • 00630414204628 ()
  • 00630414010595 ()
118826

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Prolactin (Ref) - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10331586
In Commercial Distribution

  • 00630414204604 ()
  • 00630414010588 ()
118828

  • Prolactin IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® TSH (5-pack)
Siemens Healthcare Diagnostics Inc.
10337442
In Commercial Distribution

  • 00630414204581 ()
118830

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Folic Acid - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310308
In Commercial Distribution

  • 00630414204192 ()
118551

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Vancomycin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310300
Not in Commercial Distribution

  • 00630414203928 ()
118451

  • Vancomycin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Prostate-specific Antigen (PSA) Assay Kit (5-pack) 500T
Siemens Healthcare Diagnostics Inc.
10310293
In Commercial Distribution

  • 00630414202990 ()
  • 00630414601731 ()
118157

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Prostate-specific Antigen (PSA) Master Curve Material Kit
Siemens Healthcare Diagnostics Inc.
10310294
In Commercial Distribution

  • 00630414202952 ()
118197

  • Total prostate specific antigen (tPSA) IVD, control
Rubella IgG - CENTAUR - CONS - 3x2x2,7mL
Siemens Healthcare Diagnostics Inc.
10310284
In Commercial Distribution

  • 00630414201429 ()
117711

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control
Rubella IgG Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310283
In Commercial Distribution

  • 00630414201412 ()
117710

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Multidil 11 (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310281
In Commercial Distribution

  • 00630414197739 ()
  • 00630414003320 ()
117228

  • Buffered sample diluent IVD
Multidil 10 Readypack (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310280
In Commercial Distribution

  • 00630414197722 ()
  • 00630414003313 ()
117227

  • Buffered sample diluent IVD
HCG total Diluent (6PK) - CENTAUR - CAL - 6x25mL
Siemens Healthcare Diagnostics Inc.
10323214
In Commercial Distribution

  • 00630414197418 ()
  • 00630414003573 ()
117157

  • Buffered sample diluent IVD
Total HCG Dil.RP (2PK) - CENTAUR - CAL - 2x25mL
Siemens Healthcare Diagnostics Inc.
10310279
In Commercial Distribution

  • 00630414197401 ()
  • 00630414003306 ()
117143

  • Buffered sample diluent IVD
Myoglobin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10329242
In Commercial Distribution

  • 00630414197197 ()
  • 00630414003641 ()
117031

  • Myoglobin IVD, kit, chemiluminescent immunoassay
Myoglobin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310277
In Commercial Distribution

  • 00630414197180 ()
117030

  • Myoglobin IVD, kit, chemiluminescent immunoassay
Calibrating Gas Kit for Siemens Healthcare Diagnostics Blood Gas Systems that use gas regulators without metering valves.
Siemens Healthcare Diagnostics Inc.
10318934
In Commercial Distribution

  • 00630414196701 ()
116769

  • Multiple blood gas analyte IVD, calibrator
BR Pretreatment - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310272
In Commercial Distribution

  • 00630414196688 ()
  • 00630414003290 ()
116746

  • Cancer antigen 27-29 (CA27-29) IVD, reagent
Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10331182
In Commercial Distribution

  • 00630414124940 ()
672183005

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311576
In Commercial Distribution

  • 00630414124933 ()
672183000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Ferritin/VitB12 (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10334728
In Commercial Distribution

  • 00630414124926 ()
672182005

  • Multiple anaemia-related analyte IVD, calibrator
Ferritin/VitB12 - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10311575
In Commercial Distribution

  • 00630414124919 ()
672182000

  • Multiple anaemia-related analyte IVD, calibrator
CK-MB - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311570
In Commercial Distribution

  • 00630414124803 ()
672174000

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
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
Ferritin/VitB12 - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10311568
In Commercial Distribution

  • 00630414124780 ()
672172000

  • Multiple anaemia-related analyte IVD, calibrator
Cortisol Urin - CENTAUR - CTL - 1x50mL
Siemens Healthcare Diagnostics Inc.
10318246
In Commercial Distribution

  • 00630414121819 ()
570408

  • Total cortisol IVD, reagent
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
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® 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
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
500 blood collection capillary tubes. Each tube contains 130-200 units/mL Lithium Heparin (approx. volume 140µL)
Siemens Healthcare Diagnostics Inc.
10327012
In Commercial Distribution

  • 00630414115856 ()
  • 00630414009599 ()
478608

  • Capillary blood collection tube IVD, lithium heparin
100 capillary caps. An in vitro diagnostics medical device for use with Siemens Healthcare Diagnostics Multicap® and Multicap-S 2.34mm OD blood collection capillary tubes.
Siemens Healthcare Diagnostics Inc.
10311054
In Commercial Distribution

  • 00630414115801 ()
  • 00630414009292 ()
478605

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
50 blood collection capillary tubes. Each tube contains 130-200 units/mL Lithium Heparin (approx. volume 140µL)
Siemens Healthcare Diagnostics Inc.
10327283
In Commercial Distribution

  • 00630414115788 ()
  • 00630414009605 ()
478604

  • Capillary blood collection tube IVD, lithium heparin
200 capillary caps. An in vitro diagnostics medical device for use with Siemens Healthcare Diagnostics. 1.65mm OD Glass blood collection capillary tubes.
Siemens Healthcare Diagnostics Inc.
10311053
In Commercial Distribution

  • 00630414115764 ()
  • 00630414009285 ()
478601

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
pH Electrode Fill Solution (Pack of 3). An In vitro diagnostic medical device for use on RAPIDLab® series analyzers.
Siemens Healthcare Diagnostics Inc.
10311046
In Commercial Distribution

  • 00630414115269 ()
  • 00630414010069 ()
478533

  • Hydrogen (H+)/pH electrode IVD
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