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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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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® FOL MCM - 00630414208671

Folic Acid Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310324
In Commercial Distribution

  • 00630414208671 ()
120302

  • Folate (vitamin B9) IVD, control

POCcelerator™ Data Management System - 00630414208275

No Description
Siemens Healthcare Diagnostics Inc.
10732871
In Commercial Distribution

  • 00630414208275 ()
CWT-80001

  • Medical equipment clinical data interfacing software

ADVIA Centaur® FSH - 00630414204666

ADVIA Centaur® FSH (5-pack)
Siemens Healthcare Diagnostics Inc.
10337964
In Commercial Distribution

  • 00630414204666 ()
  • 00630414010601 ()
118821

  • Follicle stimulating hormone (FSH) 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® PRGE - 00630414204147

Progesterone - CENTAUR - RGT - 50 tests
Siemens Healthcare Diagnostics Inc.
10310305
In Commercial Distribution

  • 00630414204147 ()
118530

  • Progesterone 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

Luer Capillary - 00630414202433

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
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