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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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neXus - 00841626102965

neXus BoneScalpel® 20mm, Blunt Blade & Tubeset
MISONIX, INC.
110-31-1120
In Commercial Distribution

  • 00841626103269 ()
  • 00841626102965 ()


  • Hard-tissue ultrasonic surgical system handpiece tip

neXus - 00841626102958

neXus BoneScalpel® 10mm, Blunt Blade & Tubeset
MISONIX, INC.
110-31-1110
In Commercial Distribution

  • 00841626103252 ()
  • 00841626102958 ()


  • Hard-tissue ultrasonic surgical system handpiece tip

Negative Control Serum - 10888234400622

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403887
Not in Commercial Distribution

  • 10888234400622 ()
403887

  • HLA class II antigen tissue typing IVD, kit, multiplex

Positive Control Serum - 10888234400615

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403892
Not in Commercial Distribution

  • 10888234400615 ()
403892

  • HLA class II antigen tissue typing IVD, kit, multiplex

Negative Control Serum - 10888234400592

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628209
Not in Commercial Distribution

  • 10888234400592 ()
628209

  • HLA class I antigen tissue typing IVD, kit, multiplex

Positive Control Serum - 10888234400585

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628208
Not in Commercial Distribution

  • 10888234400585 ()
628208

  • HLA class I antigen tissue typing IVD, kit, multiplex

LIFECODES Wash Buffer - 10888234400578

For Use with LIFECODES Class I ID and LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
628221
Not in Commercial Distribution

  • 10888234400578 ()
628221

  • HLA class I antigen tissue typing IVD, kit, multiplex

LIFECODES Class II IDv2 for use with Luminex - 10888234400301

LIFECODES Class II IDv2 is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628223
In Commercial Distribution

  • 10888234400301 ()
628223

  • HLA class II antigen tissue typing IVD, kit, multiplex

LIFECODES Class I ID Typing Kit for use with Luminex - 10888234400295

LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628200
In Commercial Distribution

  • 10888234400295 ()
628200

  • HLA class I antigen tissue typing IVD, kit, multiplex

PreciControl Anti-HCV - 07613336183144

No Description
Roche Diagnostics GmbH
03290379162
In Commercial Distribution

  • 07613336183144 ()
03290379162

  • Hepatitis C virus total antibody IVD, control
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