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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LOCI Vitamin B12 Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10463371
In Commercial Distribution

  • 00630414976624 ()
  • 00630414005508 ()
RF642

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
LOCI Folate Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10463370
In Commercial Distribution

  • 00630414976617 ()
  • 00630414005492 ()
RF644

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
The Stratus® CS Acute Care(TM) D-dimer assay (DDMR) is an in vitro diagnostic test for the quantitative measurement of cross-linked fibrin degradation products (D-dimer) in human citrated or heparinized plasma on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10701511
In Commercial Distribution

  • 00630414986166 ()
  • 00630414010014 ()
CDDMRE

  • D-dimer IVD, kit, fluorescent immunoassay
LP(A) - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285017
In Commercial Distribution

  • 00630414558257 ()
4865268

  • Lipoprotein A IVD, calibrator
Fructosamine - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285684
Not in Commercial Distribution

  • 00630414558240 ()
  • 00630414002996 ()
4865217

  • Fructosamine IVD, calibrator
Myoglobin Kit - ADVIA Chem. - CAL
Siemens Healthcare Diagnostics Inc.
10285682
Not in Commercial Distribution

  • 00630414558233 ()
4865160

  • Myoglobin IVD, calibrator
B2 Microglobulin - ADVIA Chem. - CAL - 3x1mL
Siemens Healthcare Diagnostics Inc.
10285680
Not in Commercial Distribution

  • 00630414558226 ()
  • 00630414002989 ()
4865101

  • Beta-2-microglobulin IVD, calibrator
Lipoprotein - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361942
In Commercial Distribution

  • 00630414558080 ()
4862528

  • Lipoprotein A IVD, kit, nephelometry/turbidimetry
Fructosamine - ADVIA Chem. - RGT - 200 tests
Siemens Healthcare Diagnostics Inc.
10361941
Not in Commercial Distribution

  • 00630414558073 ()
4862501

  • Fructosamine IVD, kit, spectrophotometry
Cystatin C - ADVIA Chem. - RGT - 4x100 tests
Siemens Healthcare Diagnostics Inc.
10361930
Not in Commercial Distribution

  • 00630414557915 ()
4851534

  • Cystatin C IVD, kit, nephelometry/turbidimetry
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