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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Testosterone II - RGT -100 Tests
Siemens Healthcare Diagnostics Inc.
10696862
In Commercial Distribution

  • 00630414591131 ()
10696862

  • Total testosterone IVD, kit, chemiluminescent immunoassay
Estradiol - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10697757
In Commercial Distribution

  • 00630414591056 ()
10697757

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® Calibrator 30 (2-pack)
Siemens Healthcare Diagnostics Inc.
10697756
In Commercial Distribution

  • 00630414591049 ()
10697756

  • Multiple steroid hormone IVD, calibrator
Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10697753
In Commercial Distribution

  • 00630414590950 ()
10697753

  • Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, calibrator
Rinse additive for CLINITEK Novus® automated urine chemistry system.
Siemens Healthcare Diagnostics Inc.
10697754
In Commercial Distribution

  • 00630414590936 ()
  • 00630414010007 ()
10697754

  • Buffered wash solution IVD
Triglyceride - ADVIA Chem. - Conc. RGT - 4x1063/4x971 tests
Siemens Healthcare Diagnostics Inc.
10697575
In Commercial Distribution

  • 00630414590394 ()
  • 00630414005966 ()
10697575

  • Triglyceride IVD, kit, spectrophotometry
ADVIA Centaur® CHIV Quality Control Material
Siemens Healthcare Diagnostics Inc.
10697214
In Commercial Distribution

  • 00630414590202 ()
10697214

  • HIV1/HIV2 antigen/antibody IVD, control
Ferritin - ADVIA Chem. - RGT - 4x200 tests
Siemens Healthcare Diagnostics Inc.
10361938
In Commercial Distribution

  • 00630414590189 ()
4862277

  • Ferritin IVD, kit, nephelometry/turbidimetry
b2 Microglobulin - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361937
Not in Commercial Distribution

  • 00630414590165 ()
4862161

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry
a1 Acid Glycoprotein - ADVIA Chem. - RGT - 2x100 tests
Siemens Healthcare Diagnostics Inc.
10361936
Not in Commercial Distribution

  • 00630414590158 ()
4862129

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
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