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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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ihcDirect® PTH Ab Conjugate 15mL - 00850030934581

Clone C123
NOVODIAX, INC.
H31028-R015
In Commercial Distribution


  • Total Volume: 15 Milliliter
K31028-015

  • Parathyroid hormone (PTH) IVD, antibody

ihcDirect® PTH Ab Conjugate 5mL - 00850030934574

Clone C123
NOVODIAX, INC.
H31028-R005
In Commercial Distribution


  • Total Volume: 5 Milliliter
K31028-005

  • Parathyroid hormone (PTH) IVD, antibody

ihcDirect® Chromogranin A Ab Conjugate 15mL - 00850030934567

Clone R1004
NOVODIAX, INC.
H32035-R015
In Commercial Distribution


  • Total Volume: 15 Milliliter
K32035-015

  • Chromogranin A IVD, antibody

ihcDirect® Chromogranin A Ab Conjugate 5mL - 00850030934550

Clone R1004
NOVODIAX, INC.
H32035-R005
In Commercial Distribution


  • Total Volume: 5 Milliliter
K32035-005

  • Chromogranin A IVD, antibody

ihcDirect® CD20 Ab Conjugate 15mL - 00850030934543

Clone R272
NOVODIAX, INC.
H32029-R015
In Commercial Distribution


  • Total Volume: 15 Milliliter
K32029-015

  • CD20 cell marker IVD, kit, enzyme immunohistochemistry

ihcDirect® CD20 Ab Conjugate 5mL - 00850030934536

Clone R272
NOVODIAX, INC.
H32029-R005
In Commercial Distribution


  • Total Volume: 5 Milliliter
K32029-005

  • CD20 cell marker IVD, kit, enzyme immunohistochemistry

ihcDirect® EMA Ab Conjugate 15mL - 00850030934529

Clone C137
NOVODIAX, INC.
H31040-R015
In Commercial Distribution


  • Total Volume: 15 Milliliter
K31040-015

  • Epithelial membrane antigen (EMA) IVD, kit, enzyme immunohistochemistry

ihcDirect® EMA Ab Conjugate 5mL - 00850030934512

Clone C137
NOVODIAX, INC.
H31040-R005
In Commercial Distribution


  • Total Volume: 5 Milliliter
K31040-005

  • Epithelial membrane antigen (EMA) IVD, kit, enzyme immunohistochemistry

ihcDirect® Vimentin Ab Conjugate 15mL - 00850030934505

Clone R289
NOVODIAX, INC.
H32021-R015
In Commercial Distribution


  • Total Volume: 15 Milliliter
K32021-015

  • Vimentin IVD, kit, enzyme immunohistochemistry

ihcDirect® Vimentin Ab Conjugate 5mL - 00850030934499

Clone R289
NOVODIAX, INC.
H32021-R005
In Commercial Distribution


  • Total Volume: 5 Milliliter
K32021-005

  • Vimentin IVD, kit, enzyme immunohistochemistry
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