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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ADVIA®120/2120/2120i SHEATH/RINSE
Siemens Healthcare Diagnostics Inc.
10316869
In Commercial Distribution

  • 00630414223032 ()
T01-3664-01

  • Wash/cleaning solution IVD, automated/semi-automated system
IVD Complete Blood Count Kit CN-FREE
Siemens Healthcare Diagnostics Inc.
10341169
In Commercial Distribution

  • 00630414222950 ()
T01-3626-52

  • Full blood count IVD, kit, cell count
ADVIA®120/2120/2120i DEFOAMER
Siemens Healthcare Diagnostics Inc.
10312274
In Commercial Distribution

  • 00630414222943 ()
T01-3625-54

  • Full blood count IVD, reagent
ADVIA®120/2120/2120i SHEATH/RINSE
Siemens Healthcare Diagnostics Inc.
10312272
In Commercial Distribution

  • 00630414222929 ()
T01-3623-01

  • Wash/cleaning solution IVD, automated/semi-automated system
ADVIA®120/2120/2120i autoRETIC
Siemens Healthcare Diagnostics Inc.
10312271
In Commercial Distribution

  • 00630414222912 ()
T01-3622-54

  • Reticulocyte count IVD, kit, cell count
ADVIA®120/2120/2120i autoRETIC
Siemens Healthcare Diagnostics Inc.
10330709
In Commercial Distribution

  • 00630414222905 ()
T01-3622-51

  • Reticulocyte count IVD, kit, cell count
ADVIA®120/2120/2120i DIFF TIMEPAC®
Siemens Healthcare Diagnostics Inc.
10312270
In Commercial Distribution

  • 00630414222899 ()
T01-3621-52

  • White blood cell count IVD, kit, cell count
Enzymatic Hemoglobin A1c_E (A1c_E) Atellica CH - RGT 600T
Siemens Healthcare Diagnostics Inc.
11097536
In Commercial Distribution

  • 00630414220505 ()
11097536

  • Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry
Multidil 15 ReadyPack (2PK) - CENTAUR - 2x25 mL
Siemens Healthcare Diagnostics Inc.
11200097
In Commercial Distribution

  • 00630414211015 ()
  • 00630414223513 ()
11200097

  • Buffered sample diluent IVD
Haptoglobin (Hapt) Atellica™ CH - RGT 150T
Siemens Healthcare Diagnostics Inc.
11097643
Not in Commercial Distribution

  • 00630414210827 ()
11097643

  • Haptoglobin IVD, kit, nephelometry/turbidimetry
ISE Standard Urine - ADVIA Chem. - CAL - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311904
In Commercial Distribution

  • 00630414210247 ()
B03-4176-01

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
ISE Standard Serum - ADVIA Chem. - CAL - 2x100mL
Siemens Healthcare Diagnostics Inc.
10311903
In Commercial Distribution

  • 00630414210230 ()
B03-4175-01

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
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
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
Magnesium - ADVIA Chem. - RGT - 4x280 tests
Siemens Healthcare Diagnostics Inc.
10341119
In Commercial Distribution

  • 00630414209845 ()
B01-4148-01

  • Magnesium (Mg2+) 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
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
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