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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CA 15-3 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10312831
In Commercial Distribution

  • 00630414461328 ()
  • 00630414003481 ()
128535

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 15-3 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10327620
In Commercial Distribution

  • 00630414461311 ()
128534

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
CA 125 - CENTAUR - RGT - 500 tests
Siemens Healthcare Diagnostics Inc.
10315696
In Commercial Distribution

  • 00630414461304 ()
  • 00630414003504 ()
128533

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CA 125 - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310443
In Commercial Distribution

  • 00630414461298 ()
128532

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
CA15-3 master curve material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10330854
In Commercial Distribution

  • 00630414461281 ()
128531

  • Cancer antigen 15-3 (CA15-3) IVD, control
CA 125 II Master Curve Material Kit - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310442
In Commercial Distribution

  • 00630414461274 ()
128530

  • Cancer antigen 125 (CA125) IVD, control
Insulin - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10310439
In Commercial Distribution

  • 00630414461021 ()
128434

  • Insulin IVD, kit, chemiluminescent immunoassay
Insulin - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10310438
In Commercial Distribution

  • 00630414461014 ()
128433

  • Insulin IVD, calibrator
Insulin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10310437
In Commercial Distribution

  • 00630414461007 ()
128432

  • Insulin IVD, control
Theophyline - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
10328931
Not in Commercial Distribution

  • 00630414460963 ()
  • 00630414027661 ()
128380

  • Theophylline therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
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