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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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EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrelia burgdorferi VlsE, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020GV
In Commercial Distribution

  • 05391516748735 ()
44-2020GV

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Lyme Disease IgM IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100M
In Commercial Distribution

  • 05391516746199 ()
32-5100M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Lyme Disease IgG IFA Test System (100 Tests)
MARDX DIAGNOSTICS, INC.
32-5100G
In Commercial Distribution

  • 05391516746182 ()
32-5100G

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
The Spotted Fever Group Rickettsia IgG ELISA is intended for the detection of human IgG class antibody to Spotted Fever Group Rickettsia, to be used as an aid in the diagnosis of human infection by these pathogens.
DRG International Inc
EIA-5297
In Commercial Distribution

  • 00840239052971 ()
EIA-5297

  • Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2150-2005-4 G
Not in Commercial Distribution

  • 04049016089537 ()


  • Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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
The Spotted Fever Group Rickettsia IgG ELISA is intended for the detection of human IgG class antibody to Spotted Fever Group Rickettsia, to be used as an aid in the diagnosis of human infection by these pathogens.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5297
In Commercial Distribution

  • 04048474052978 ()
EIA-5297

  • Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
An EIA assay for spotted fever Rickettsiosis IgG levels
FULLER LABORATORIES
N/A
In Commercial Distribution

  • B266SFG96K0 ()
SFG96K

  • Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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