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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 aHBe2 50T Kit - 00630414167923

Anti-HBe2 (aHBe2) – ADVIA Centaur – RGT 50T
Siemens Healthcare Diagnostics Inc.
10720831
In Commercial Distribution

  • 00630414167923 ()
10720831

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay

TB3 K+/Ca++/Cl- Test/Blank Sensor - 00630414132075

Blank sensor to replace the K+/Ca++/Cl-sensor. An in vitro medical device used on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10311665
In Commercial Distribution

  • 00630414132075 ()
673702

  • Blood gas/haemoximetry analyser IVD, point-of-care

TB4 Glu/Lac Test/Blank Sensor - 00630414132051

Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10326708
In Commercial Distribution

  • 00630414132051 ()
673701000

  • Lactate electrode IVD

TB5 Ref Test/Blank Sensor - 00630414132013

Reference Test/Blank sensor, an in vitro diagnostics device to replace the Reference sensor on the RAPIDLab® 248/348/348ex analyzers
Siemens Healthcare Diagnostics Inc.
10327492
In Commercial Distribution

  • 00630414132013 ()
673396000

  • Blood gas/haemoximetry analyser IVD, point-of-care

MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb - 00630414131986

RAPIDLyte Multicap blood collection capillary tubes (50 tubes) approx. volume 100µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10323539
In Commercial Distribution

  • 00630414131986 ()
  • 00630414009520 ()
673394

  • Capillary blood collection tube IVD, electrolyte-balanced heparin

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

ADVIA Centaur® FT3 MCM - 00630414126289

Free T3 Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311622
In Commercial Distribution

  • 00630414126289 ()
672425000

  • Free triiodothyronine (FT3) IVD, control
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