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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 Centaur® Multi-Diluent 1 - 00630414175225

Multidil 1 (6PK) - CENTAUR - CAL - 6x25mL
Siemens Healthcare Diagnostics Inc.
10309942
In Commercial Distribution

  • 00630414175225 ()
  • 00630414003085 ()
110313

  • Buffered sample diluent IVD

ADVIA Centaur® Multi-Diluent 1 - 00630414175218

Multidil 1 Readypack(2PK) - CENTAUR - CAL - 2x25mL
Siemens Healthcare Diagnostics Inc.
10309941
In Commercial Distribution

  • 00630414175218 ()
  • 00630414003078 ()
110312

  • Buffered sample diluent IVD

ADVIA Chemistry Systems 70-mL Wedges - Yellow - 00630414168258

ADVIA Chemistry Systems 70-mL Wedges –Yellow
Siemens Healthcare Diagnostics Inc.
11223140
In Commercial Distribution

  • 00630414168258 ()
11223140

  • Assay container IVD, single-use

IMMULITE 2000 Progesterone Kit Domestic 600T - 00630414167510

IMMULITE 2000 Progesterone Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901874
In Commercial Distribution

  • 00630414167510 ()
L2KPW6(D)

  • Progesterone IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 Prolactin Kit Domestic 200T - 00630414167497

IMMULITE 2000 Prolactin Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901868
In Commercial Distribution

  • 00630414167497 ()
L2KPR2(D)

  • Prolactin IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 FSH Kit Domestic 600T - 00630414167442

IMMULITE 2000 FSH Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901859
In Commercial Distribution

  • 00630414167442 ()
L2KFS6(D)

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® PRL MCM - 00630414126326

Prolactin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311626
In Commercial Distribution

  • 00630414126326 ()
672430000

  • Prolactin IVD, control

ADVIA Centaur® Systems, ACS 180® Systems AFP MCM - 00630414126319

Alpha-Fetoprotein (AFP) Master Curve Material Kit
Siemens Healthcare Diagnostics Inc.
10311625
In Commercial Distribution

  • 00630414126319 ()
672428000

  • Alpha-fetoprotein (AFP) IVD, control

ADVIA Centaur® CEA MCM - 00630414126302

CEA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311624
In Commercial Distribution

  • 00630414126302 ()
672427000

  • Carcinoembryonic antigen (CEA) IVD, control

ADVIA Centaur® DIG MCM - 00630414126296

Digoxin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311623
In Commercial Distribution

  • 00630414126296 ()
672426000

  • Digoxin therapeutic drug monitoring IVD, control
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