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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® cPSA PRE - 00630414451558

Complexed Prostate-specific Antigen (cPSA) Pre-Treatment Reagent 1-pack
Siemens Healthcare Diagnostics Inc.
10310384
In Commercial Distribution

  • 00630414451558 ()
125308

  • Complexed prostate specific antigen (cPSA) IVD, reagent

ADVIA Centaur® PW 1 - 00630414451220

Probe Wash - CENTAUR - CONS - 1x250 Best.
Siemens Healthcare Diagnostics Inc.
10310358
In Commercial Distribution

  • 00630414451220 ()
123738

  • Buffered wash solution IVD

ADVIA Centaur® Systems. ACS:180® Systems Calibrator Y - 00630414451114

Calibrator Y - 2 pack (cPSA Cal)
Siemens Healthcare Diagnostics Inc.
10310383
In Commercial Distribution

  • 00630414451114 ()
125014

  • Complexed prostate specific antigen (cPSA) IVD, calibrator

ADVIA Centaur® FOL Ascorbic Acid Diluent DIL - 00630414451077

Ascorbic Acid - CENTAUR - CAL - 4x30mL
Siemens Healthcare Diagnostics Inc.
10316877
In Commercial Distribution

  • 00630414451077 ()
124975

  • Folate (vitamin B9) IVD, reagent

ADVIA Centaur® FOL DTT/Releasing Agent - 00630414451060

Folate DTT/REL AGT - CENTAUR - CONS - 600 Best.
Siemens Healthcare Diagnostics Inc.
10310382
In Commercial Distribution

  • 00630414451060 ()
124974

  • Dithiothriotol (DTT) reagent IVD

ADVIA Centaur® FOL - 00630414450940

Folic Acid - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10325366
In Commercial Distribution

  • 00630414450940 ()
124838

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

ADVIA Centaur® cPSA - 00630414450896

Complexed Prostate-specific Antigen (cPSA) Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
10310381
In Commercial Distribution

  • 00630414450896 ()
124830

  • Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Systems, ACS 180® Systems cPSA MCM - 00630414450872

Complexed Prostate-specific Antigen (cPSA) Master Curve Material Kit
Siemens Healthcare Diagnostics Inc.
10310380
In Commercial Distribution

  • 00630414450872 ()
124828

  • Complexed prostate specific antigen (cPSA) IVD, control

ADVIA Centaur® CA 19-9 MCM - 00630414447926

CA19-9 master material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10325894
In Commercial Distribution

  • 00630414447926 ()
123518

  • Cancer antigen 19-9 (CA19-9) IVD, control

RAPIDPoint® 400/405/500 Wash/Waste Cartridge - 00630414444581

RAPIDPoint® 400/405/500 Wash/Waste Cartridge is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 400/405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10310310
In Commercial Distribution

  • 00630414444581 ()
  • 00630414009223 ()
118677

  • Wash/cleaning solution IVD, automated/semi-automated system
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