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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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RAPIDChem® 744 - 00630414471112

The Rapidchem® 744 analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), and Cl- (chloride) or Lithium (Li+) in serum, plasma, whole blood and urine (not applicable for Lithium) samples.
Siemens Healthcare Diagnostics Inc.
10324039
In Commercial Distribution

  • 00630414471112 ()
6254738

  • Ion-selective analyser IVD, semi-automated

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 Centaur® HBc IgM - 00630414470498

HBc IgM (aHBcM) Assay Kit - 100T
Siemens Healthcare Diagnostics Inc.
10308978
In Commercial Distribution

  • 00630414470498 ()
504619

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

ADVIA® Chemistry DIG Digoxin Reagents - 00630414470375

Digoxin - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10327549
Not in Commercial Distribution

  • 00630414470375 ()
B01-4769-01

  • Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry TDM Calibrator - 00630414470351

TDM - ADVIA Chem. - CAL - 6x3mL
Siemens Healthcare Diagnostics Inc.
10311922
Not in Commercial Distribution

  • 00630414470351 ()
B03-4790-01

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

ADVIA® Chemistry HDL/LDL Cholesterol Calibrator - 00630414470313

HDL/LDL Cholesterol - ADVIA Chem. - CAL - 3x1mL
Siemens Healthcare Diagnostics Inc.
10311918
In Commercial Distribution

  • 00630414470313 ()
  • 00630414003443 ()
B03-4763-01

  • Multiple lipid analyte IVD, calibrator

ADVIA Centaur® H2n MCM - 00630414469850

HER-2/NEU Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10324496
In Commercial Distribution

  • 00630414469850 ()
131217

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

ADVIA Centaur® FOL (25-pack) - 00630414469454

TBD
Siemens Healthcare Diagnostics Inc.
10340209
In Commercial Distribution

  • 00630414469454 ()
131096

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

RAPIDPoint® 400 Measurement Cartridge - 00630414469225

RAPIDPoint® 400 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct. For in vitro diagnostic use with RAPIDPoint ® 400 systems.
Siemens Healthcare Diagnostics Inc.
10329756
In Commercial Distribution

  • 00630414469225 ()
130517

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