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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 Direct LDL Cholesterol Reagents - 00630414470542

LDL Cholesterol - ADVIA Chem. - RGT - 4x188 tests
Siemens Healthcare Diagnostics Inc.
10311891
In Commercial Distribution

  • 00630414470542 ()
B01-4760-01

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

ADVIA Centaur® Systems HBc IgM QC - 00630414470504

HBc IgM (aHBcM) Quality Control Material Kit
Siemens Healthcare Diagnostics Inc.
10308979
In Commercial Distribution

  • 00630414470504 ()
504945

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

ADVIA® Chemistry TDM Calibrator - 00630414470351

TDM - ADVIA Chem. - CAL - 6x3mL
Siemens Healthcare Diagnostics Inc.
10311922
In Commercial Distribution

  • 00630414470351 ()
B03-4790-01

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA Centaur® HCY - 00630414468181

Homocystein - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10310375
In Commercial Distribution

  • 00630414468181 ()
124578

  • Homocysteine IVD, kit, chemiluminescent immunoassay

Ready Sensor™ Lactate Biosensor - 00630414468143

Ready Sensor™ Lactate Biosensor is an in vitro diagnostic medical device for the measurement of lactate in Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10316526
In Commercial Distribution

  • 00630414468143 ()
  • 00630414009445 ()
2144067

  • Lactate electrode IVD

Gas Pressure Regulator - 00630414467818

Two stage gas Pressure Regulator for Siemens Healthcare Diagnostics Blood Gas Systems
Siemens Healthcare Diagnostics Inc.
10310422
In Commercial Distribution

  • 00630414467818 ()
127191

  • Multiple blood gas analyte IVD, calibrator

ADVIA Centaur® IRI - 00630414466200

Insulin Diluent - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10310463
In Commercial Distribution

  • 00630414466200 ()
129885

  • Buffered sample diluent IVD

ADVIA Centaur® IRI DIL - 00630414466187

Insulin Dil.RP (2PK) - CENTAUR - CAL - 2x10mL
Siemens Healthcare Diagnostics Inc.
10310462
In Commercial Distribution

  • 00630414466187 ()
  • 00630414003375 ()
129883

  • Buffered sample diluent IVD

RAPIDSystems™ AutomaticQC Cartridge - 00630414465883

For in vitro diagnostic use for multi-level quality control of RAPIDPoint 400/500 series and RAPIDLab 1200 series systems.
Siemens Healthcare Diagnostics Inc.
10310323
In Commercial Distribution

  • 00630414465883 ()
120241

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

ADVIA® Chemistry CHE Cholinesterase Reagents - 00630414465401

PCHE - ADVIA Chem. - RGT - 4x133 tests
Siemens Healthcare Diagnostics Inc.
10329639
In Commercial Distribution

  • 00630414465401 ()
B01-4605-01

  • Acetylcholinesterase IVD, kit, spectrophotometry
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