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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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Atellica CH A1c_E Calibrator - 00630414220512

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

ADVIA® Chemistry Cuvette Wash Solution - 00630414210001

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

  • 00630414210001 ()
B01-4178-51

  • Buffered wash solution IVD

ADVIA® Chemistry ISE Buffer - 2 liter - 00630414209968

ISE Buffer - ADVIA Chem. - CONS - 2 Liter
Siemens Healthcare Diagnostics Inc.
10311849
In Commercial Distribution

  • 00630414209968 ()
B01-4171-51

  • pH-adjusted buffer solution IVD

ADVIA® Chemistry GGT Reagents - 00630414209753

GGT - ADVIA Chem. - RGT - 4x675 tests
Siemens Healthcare Diagnostics Inc.
10316298
In Commercial Distribution

  • 00630414209753 ()
B01-4138-01

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry

ADVIA® Chemistry TRIG Triglycerides Reagents - 00630414209708

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 - 00630414204703

ADVIA Centaur® FER (5-pack)
Siemens Healthcare Diagnostics Inc.
10340414
In Commercial Distribution

  • 00630414204703 ()
  • 00630414010625 ()
118815

  • Ferritin IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® LH - 00630414204628

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

ADVIA Centaur® Prolactin (PRL) - 00630414204604

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 - 00630414204581

ADVIA Centaur® TSH (5-pack)
Siemens Healthcare Diagnostics Inc.
10337442
In Commercial Distribution

  • 00630414204581 ()
118830

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® FOL - 00630414204192

Folic Acid - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310308
In Commercial Distribution

  • 00630414204192 ()
118551

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® VANC - 00630414203928

Vancomycin - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310300
Not in Commercial Distribution

  • 00630414203928 ()
118451

  • Vancomycin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® PSA - 00630414202990

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

ADVIA Centaur® Systems, ACS 180® Systems PSA MCM - 00630414202952

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

ADVIA Centaur® Rub G QC - 00630414201429

Rubella IgG - CENTAUR - CONS - 3x2x2,7mL
Siemens Healthcare Diagnostics Inc.
10310284
In Commercial Distribution

  • 00630414201429 ()
117711

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

ADVIA Centaur® Rub G - 00630414201412

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

ADVIA Centaur® Multi-Diluent 11 - 00630414197739

Multidil 11 (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10310281
In Commercial Distribution

  • 00630414197739 ()
  • 00630414003320 ()
117228

  • Buffered sample diluent IVD

ADVIA Centaur® Multi-Diluent 10 - 00630414197722

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

  • 00630414197722 ()
  • 00630414003313 ()
117227

  • Buffered sample diluent IVD

ADVIA Centaur® ThCG Diluent - 00630414197418

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

  • 00630414197418 ()
  • 00630414003573 ()
117157

  • Buffered sample diluent IVD

ADVIA Centaur® ThCG DIL - 00630414197401

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

  • 00630414197401 ()
  • 00630414003306 ()
117143

  • Buffered sample diluent IVD

ADVIA Centaur® MYO +U - 00630414197197

Myoglobin - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10329242
In Commercial Distribution

  • 00630414197197 ()
  • 00630414003641 ()
117031

  • Myoglobin IVD, kit, chemiluminescent immunoassay
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