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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ApolipoproteinA1/B - ADVIA Chem. - CAL - 5x1mL
Siemens Healthcare Diagnostics Inc.
10311898
In Commercial Distribution

  • 00630414210131 ()
  • 00630414003436 ()
B03-4161-01

  • Multiple apolipoprotein IVD, calibrator
No Description
Siemens Healthcare Diagnostics Inc.
10732943
In Commercial Distribution

  • 00630414210100 ()
10732943

  • Medical equipment clinical data interfacing software
Reagent Probe Wash 3 - ADVIA Chem. - CONS - 1x500mL
Siemens Healthcare Diagnostics Inc.
10311858
In Commercial Distribution

  • 00630414210087 ()
B01-4183-51

  • Buffered wash solution IVD
Reagent Probe Wash 2 - ADVIA Chem. - CONS - 5x250mL
Siemens Healthcare Diagnostics Inc.
10311857
In Commercial Distribution

  • 00630414210070 ()
  • 00630414003429 ()
B01-4182-55

  • Buffered wash solution IVD
Reagent Probe Wash 1 - ADVIA Chem. - CONS - 5x250mL
Siemens Healthcare Diagnostics Inc.
10311856
In Commercial Distribution

  • 00630414210056 ()
  • 00630414003412 ()
B01-4181-55

  • Buffered wash solution IVD
Cuvette conditioner - ADVIA Chem. - CONS - 1x1000mL
Siemens Healthcare Diagnostics Inc.
10311854
In Commercial Distribution

  • 00630414210025 ()
B01-4179-51

  • Buffered wash solution IVD
Cuvette wash solution - ADVIA Chem. - CONS - 1x2000mL
Siemens Healthcare Diagnostics Inc.
10311853
In Commercial Distribution

  • 00630414210001 ()
B01-4178-51

  • Buffered wash solution IVD
ISE DET Solution - ADVIA Chem. - CONS - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311851
In Commercial Distribution

  • 00630414209982 ()
  • 00630414003405 ()
B01-4174-52

  • Wash/cleaning solution IVD, automated/semi-automated system
ISE Buffer - ADVIA Chem. - CONS - 2 Liter
Siemens Healthcare Diagnostics Inc.
10311849
In Commercial Distribution

  • 00630414209968 ()
B01-4171-51

  • pH-adjusted buffer solution IVD
Magnesium - ADVIA Chem. - RGT - 4x280 tests
Siemens Healthcare Diagnostics Inc.
10341119
In Commercial Distribution

  • 00630414209845 ()
B01-4148-01

  • Magnesium (Mg2+) IVD, kit, spectrophotometry
GGT - ADVIA Chem. - RGT - 4x675 tests
Siemens Healthcare Diagnostics Inc.
10316298
In Commercial Distribution

  • 00630414209753 ()
B01-4138-01

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
CK - ADVIA Chem. - RGT - 4x270 tests
Siemens Healthcare Diagnostics Inc.
10341111
Not in Commercial Distribution

  • 00630414209746 ()
  • 00630414003740 ()
B01-4137-01

  • Total creatine kinase (CK) IVD, kit, enzyme 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
Albumin - ADVIA Chem. - RGT - 4x555/4x232 tests
Siemens Healthcare Diagnostics Inc.
10311832
In Commercial Distribution

  • 00630414209586 ()
  • 00630414003382 ()
B01-4121-01

  • Albumin IVD, kit, nephelometry/turbidimetry
Phenytoin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10328805
Not in Commercial Distribution

  • 00630414209135 ()
  • 00630414027654 ()
120539

  • Phenytoin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Phenytoin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310328
Not in Commercial Distribution

  • 00630414209128 ()
120538

  • Phenytoin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Free T3 (Ref) - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10332537
In Commercial Distribution

  • 00630414209050 ()
  • 00630414010670 ()
120485

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
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
Folic Acid Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310324
In Commercial Distribution

  • 00630414208671 ()
120302

  • Folate (vitamin B9) 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
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
Progesterone - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310305
In Commercial Distribution

  • 00630414204147 ()
118530

  • Progesterone 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
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 (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) 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
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