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 Class Implantable

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Test/Blank Sensor in vitro diagnostics device to replace the pO2/pCO2 sensors on the 1200 series instruments
Siemens Healthcare Diagnostics Inc.
10316620
In Commercial Distribution

  • 00630414515250 ()
2195443

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Waste Bottle Kit. An in vitro diagnostics device for use on the RAPIDLab® 1200 series analyzer.
Siemens Healthcare Diagnostics Inc.
10324896
In Commercial Distribution

  • 00630414515144 ()
  • 00630414010489 ()
6641057

  • Contaminated waste container
Probe Wash 2 - CENTAUR - CONS - 2x25mL
Siemens Healthcare Diagnostics Inc.
10316997
In Commercial Distribution

  • 00630414514413 ()
  • 00630414003528 ()
2416113

  • Buffered wash solution IVD
Iron - ADVIA Chem. - RGT - 7x145 tests
Siemens Healthcare Diagnostics Inc.
10341118
In Commercial Distribution

  • 00630414513157 ()
2194838

  • Iron IVD, kit, spectrophotometry
IgA - ADVIA Chem. - RGT - 5x75 tests
Siemens Healthcare Diagnostics Inc.
10309033
In Commercial Distribution

  • 00630414513133 ()
2194102

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
IgM - ADVIA Chem. - RGT - 4x90 tests
Siemens Healthcare Diagnostics Inc.
10309032
In Commercial Distribution

  • 00630414513126 ()
2193483

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
IgG - ADVIA Chem. - RGT - 4x90 tests
Siemens Healthcare Diagnostics Inc.
10309031
In Commercial Distribution

  • 00630414513119 ()
2193432

  • Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
Calcium - ADVIA Chem. - RGT - 7x290/7x230 tests
Siemens Healthcare Diagnostics Inc.
10341116
In Commercial Distribution

  • 00630414513102 ()
  • 00630414003757 ()
2189915

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Calcium - ADVIA Chem. - RGT - 8x550/8x430 tests
Siemens Healthcare Diagnostics Inc.
10316612
In Commercial Distribution

  • 00630414513096 ()
  • 00630414003511 ()
2189699

  • Calcium (Ca2+) IVD, kit, spectrophotometry
Bilirubin Direct - ADVIA Chem. - RGT - 4x130 tests
Siemens Healthcare Diagnostics Inc.
10316610
In Commercial Distribution

  • 00630414513089 ()
2189494

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
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