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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TOXO IgM - CENTAUR - CONS - 2x2x1,5mL
Siemens Healthcare Diagnostics Inc.
10310326
In Commercial Distribution

  • 00630414208763 ()
120383

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control
TOXO IgG - CENTAUR - CONS - 2x2x2,7mL
Siemens Healthcare Diagnostics Inc.
10310325
In Commercial Distribution

  • 00630414208756 ()
120382

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Toxoplasma IgG Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310321
In Commercial Distribution

  • 00630414208459 ()
120154

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Toxoplasma IgM Ab - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310320
In Commercial Distribution

  • 00630414208442 ()
120153

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
Siemens Healthcare Diagnostics Inc.
10732871
In Commercial Distribution

  • 00630414208275 ()
CWT-80001

  • Medical equipment clinical data interfacing software
Free T3 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10310318
In Commercial Distribution

  • 00630414207537 ()
  • 00630414003337 ()
119781

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Free T3 - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310317
In Commercial Distribution

  • 00630414207520 ()
119780

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Digitoxin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10329308
Not in Commercial Distribution

  • 00630414207414 ()
  • 00630414003658 ()
119714

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® BR (5-pack)
Siemens Healthcare Diagnostics Inc.
10340081
In Commercial Distribution

  • 00630414204772 ()
  • 00630414010663 ()
118803

  • Cancer antigen 27-29 (CA27-29) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® VB12 (5-pack)
Siemens Healthcare Diagnostics Inc.
10336453
In Commercial Distribution

  • 00630414204758 ()
  • 00630414010656 ()
118806

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Carcino-Embryonic Antigen (Ref) - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10333162
In Commercial Distribution

  • 00630414204741 ()
  • 00630414010632 ()
118808

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® FER (5-pack)
Siemens Healthcare Diagnostics Inc.
10340414
In Commercial Distribution

  • 00630414204703 ()
  • 00630414010625 ()
118815

  • Ferritin IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® FSH (5-pack)
Siemens Healthcare Diagnostics Inc.
10337964
In Commercial Distribution

  • 00630414204666 ()
  • 00630414010601 ()
118821

  • Follicle stimulating hormone (FSH) 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
Digitoxin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310301
Not in Commercial Distribution

  • 00630414203935 ()
118453

  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Prostate-specific Antigen (PSA) Assay Kit (1-pack) 100T
Siemens Healthcare Diagnostics Inc.
10310292
In Commercial Distribution

  • 00630414203003 ()
118156

  • 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
Calibrator Q - 2 pack (PSA Cal)
Siemens Healthcare Diagnostics Inc.
10310295
In Commercial Distribution

  • 00630414202938 ()
118220

  • Total prostate specific antigen (tPSA) IVD, calibrator
Calibrator Q - 6 pack (PSA Cal)
Siemens Healthcare Diagnostics Inc.
10310296
In Commercial Distribution

  • 00630414202921 ()
118221

  • Total prostate specific antigen (tPSA) IVD, calibrator
Luer Capillary (pack of 2) an in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzers.
Siemens Healthcare Diagnostics Inc.
10323407
In Commercial Distribution

  • 00630414299181 ()
  • 00630414202433 ()
106050

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers.
Siemens Healthcare Diagnostics Inc.
10309927
In Commercial Distribution

  • 00630414202167 ()
  • 00630414009216 ()
108869

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
For in vitro diagnostic use for quality control of pH/Blood Gas Analyzers, ISE Analyzers, CO-oximeters and Metabolite Analyzers.
Siemens Healthcare Diagnostics Inc.
10309925
In Commercial Distribution

  • 00630414202150 ()
  • 00630414009193 ()
108860

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Rubella IgM - CENTAUR - CONS - 2x2x2,7mL
Siemens Healthcare Diagnostics Inc.
10310286
In Commercial Distribution

  • 00630414201443 ()
117734

  • Rubella virus immunoglobulin M (IgM) antibody IVD, control
Rubella IgM Ab - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310285
In Commercial Distribution

  • 00630414201436 ()
117733

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