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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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No Description
Roche Diagnostics GmbH
09014918160
In Commercial Distribution

  • 07613336203606 ()
09014918160

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08814856160
In Commercial Distribution

  • 07613336198285 ()
08814856160

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
HBsAg Confirmatory Test Elecsys cobas e V2
Roche Diagnostics GmbH
09127127190
In Commercial Distribution

  • 07613336175293 ()
09127127190

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08741034190
In Commercial Distribution

  • 07613336172902 ()
08741034190

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08838534160
In Commercial Distribution

  • 07613336167496 ()
08838534160

  • Total prostate specific antigen (tPSA) IVD, calibrator
No Description
Roche Diagnostics GmbH
08791716160
In Commercial Distribution

  • 07613336166000 ()
08791716160

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08791686160
In Commercial Distribution

  • 07613336165997 ()
08791686160

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08791732190
In Commercial Distribution

  • 07613336165980 ()
08791732190

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08741107190
In Commercial Distribution

  • 07613336164372 ()
08741107190

  • Hepatitis B virus surface antigen IVD, control
No Description
Roche Diagnostics GmbH
08498598160
In Commercial Distribution

  • 07613336160367 ()
08498598160

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
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