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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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RAPIDPoint® 405/500 Measurement Cartridge (100 tests) - pH, pCO2, pO2, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers.
Siemens Healthcare Diagnostics Inc.
10844811
In Commercial Distribution

  • 00630414947532 ()
10844811

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 400 Measurement Cartridge (100 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct is an invitro diagnostics device which is intended to be used on the RAPIDPoint® 400 analyzer.
Siemens Healthcare Diagnostics Inc.
10844810
In Commercial Distribution

  • 00630414947525 ()
10844810

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
IMMULITE® 1000 Instrument, 110 VOLT
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10380058
In Commercial Distribution

  • 00630414947440 ()
030006-03

  • Chemiluminescent immunoassay analyser IVD
HBsAg Confirmatory Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706825
In Commercial Distribution

  • 00630414947433 ()
L2KCH1(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
ALBP KIT - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10711842
In Commercial Distribution

  • 00630414947426 ()
  • 00630414006079 ()
10711842

  • Albumin IVD, calibrator
Albumin - ADVIA Chem. - RGT - 4x1525
Siemens Healthcare Diagnostics Inc.
10711841
In Commercial Distribution

  • 00630414947419 ()
  • 00630414006055 ()
10711841

  • Albumin IVD, kit, spectrophotometry
Albumin - ADVIA Chem. - RGT - 4x800
Siemens Healthcare Diagnostics Inc.
10711840
In Commercial Distribution

  • 00630414947402 ()
  • 00630414006031 ()
10711840

  • Albumin IVD, kit, spectrophotometry
The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10459330
In Commercial Distribution

  • 00630414945514 ()
OVOB03

  • Coagulation analyser IVD, laboratory
IMMULITE® 2000 XPi Instrument
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10373214
In Commercial Distribution

  • 00630414945422 ()
030002-33

  • Chemiluminescent immunoassay analyser IVD
Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT)
Siemens Healthcare Diagnostics Inc.
11700159
In Commercial Distribution

  • 00630414321486 ()
  • 00630414652597 ()
11700159

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
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