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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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Syphilis PC Elecsys
Roche Diagnostics GmbH
06923364162
In Commercial Distribution

  • 07613336183175 ()
06923364162

  • Treponema pallidum total antibody IVD, control
No Description
Roche Diagnostics GmbH
04784600162
In Commercial Distribution

  • 07613336183151 ()
04784600162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
No Description
Roche Diagnostics GmbH
09015051162
In Commercial Distribution

  • 07613336228463 ()
  • 07613336183083 ()
09015051162

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
09118551162
In Commercial Distribution

  • 07613336228449 ()
  • 07613336183069 ()
09118551162

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, kit, chemiluminescent immunoassay
PreciControl Release Syphilis
Roche Diagnostics GmbH
09366903190
In Commercial Distribution

  • 07613336183007 ()
09366903190

  • Treponema pallidum total antibody IVD, control
No Description
Roche Diagnostics GmbH
09366679190
In Commercial Distribution

  • 07613336182987 ()
09366679190

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody avidity index IVD, control
No Description
Roche Diagnostics GmbH
08924180160
In Commercial Distribution

  • 07613336170212 ()
08924180160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08924163160
In Commercial Distribution

  • 07613336170182 ()
08924163160

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
MCS+ ,110V ENGL, LN 09000-110-E
HAEMONETICS CORPORATION
09000-110-E
In Commercial Distribution

  • 30812747012816 ()


  • Apheresis system
PCS2, LIST NO. 06002-220-EXP-EW
HAEMONETICS CORPORATION
06002-220-EXP-EW
In Commercial Distribution

  • 30812747011963 ()


  • Autotransfusion system blood component processing set
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