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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
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1010-4 G
Not in Commercial Distribution

  • 04049016089520 ()


  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-1005-4 G
Not in Commercial Distribution

  • 04049016089513 ()


  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
DIASORIN MOLECULAR LLC
EL0312
In Commercial Distribution

  • 10816101022042 ()
EL0312

  • West Nile virus immunoglobulin M (IgM) antibody IVD, control
  • West Nile virus immunoglobulin G (IgG) antibody IVD, control
TSC Uni-Planar Screw 7.0 x 35mm
Seaspine, Inc.
70-7035
Not in Commercial Distribution

  • M5567070351 ()
  • 10381780006046 ()

  • 7.0 x 35mm
70-7035

  • Multiple Rickettsia species (typhus group) immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
VZN-7010
In Commercial Distribution

  • B110VZN70100 ()
VZN-7010

  • Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, control
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, control
Each dropper bottle contains 2.7 ml of latex reagent for the detection of Legionella micdadei from culture plates.
PRO-LAB, INCORPORATED
PL.221
In Commercial Distribution

  • 10628429001810 ()
PL.221

  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
L. pneumophila serogroup 2
PRO-LAB, INCORPORATED
PL.210
In Commercial Distribution

  • 10628429001728 ()
PL.210

  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
KITAZATO CORPORATION
CryotopCL(G)
In Commercial Distribution

  • 14582231461957 ()
  • 04582231461950 ()


  • Assisted reproduction vitrification carrier
No Description
KITAZATO CORPORATION
CryotopSC(G)
In Commercial Distribution

  • 14582231461902 ()
  • 04582231461905 ()


  • Assisted reproduction vitrification carrier
Cryopreservation storage devices that are intended for use in vitrificationprocedures to contain and maintain human oocytes (MII) and embryos.
KITAZATO CORPORATION
CryotopUS-scoop(G)
In Commercial Distribution

  • 14582231462848 ()
  • 04582231462841 ()
81195

  • Assisted reproduction vitrification carrier
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