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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
09366652190
In Commercial Distribution

  • 07613336182970 ()
09366652190

  • Hepatitis C virus total antibody IVD, control
JBAIDS IVD Plague Detection Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0123
Not in Commercial Distribution

  • 00851458005044 ()
JRPD-ASY-0123

  • Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Diagnostics GmbH
07092571162
In Commercial Distribution

  • 07613336183205 ()
07092571162

  • Trypanosoma cruzi total antibody IVD, control
No Description
Roche Diagnostics GmbH
08837058162
In Commercial Distribution

  • 07613336228432 ()
  • 07613336183052 ()
08837058162

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
No Description
Roche Diagnostics GmbH
09367098190
In Commercial Distribution

  • 07613336183038 ()
09367098190

  • Trypanosoma cruzi total antibody IVD, control
For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628214
Not in Commercial Distribution

  • 10888234400547 ()
628214

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628213
Not in Commercial Distribution

  • 10888234400523 ()
628213

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
LIFECODES LifeScreen Deluxe is a qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules
IMMUCOR GTI DIAGNOSTICS, INC.
628215
In Commercial Distribution

  • 10888234400318 ()
628215

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
No Description
Roche Diagnostics GmbH
04927931162
In Commercial Distribution

  • 07613336183199 ()
04927931162

  • Hepatitis B virus core total antibody IVD, control
No Description
Roche Diagnostics GmbH
09015582162
In Commercial Distribution

  • 07613336228494 ()
  • 07613336183113 ()
09015582162

  • Trypanosoma cruzi total antibody IVD, kit, chemiluminescent immunoassay
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