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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
EI 2320-9601-1 G
In Commercial Distribution

  • 04049016117124 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DY 2321-1601-1 G
In Commercial Distribution

  • 04049016116110 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2132-9601-24 O
In Commercial Distribution

  • 04049016114895 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2150-9601 G
In Commercial Distribution

  • 04049016027515 ()


  • Legionella pneumophila immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
EBV EA-D IgG EIA TEST
Bio-RAD Laboratories, Inc.
12008530
In Commercial Distribution

  • 03610522051243 ()

  • 96 Tests
12008530

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506462 ()

  • 1 Each
12000883

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
U.S. IFU, Canada IFU (United States, Canada) Manual & CDs, BioPlex 2200 Lyme Total IFU SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506455 ()

  • 1 Each
12000882

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
BioPlex 2200 Lyme Total 200 Tests
BIO-RAD LABORATORIES, INC.
12000876
In Commercial Distribution

  • 03610520506394 ()

  • 200 Tests
12000876

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN MOLECULAR LLC
IF0010
Not in Commercial Distribution

  • 10816101020017 ()


  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
The ImmunoWELL Borrelia (Lyme) Test is an enzyme immunoassay (EIA) for the qualitative and/or semi-quantitative detection of Borrelia burgdorferi total antibodies (IgG, IgM, and IgA) in serum and is used as an aid in the diagnosis of Lyme disease.
Genbio
800-3110
In Commercial Distribution

  • 00613745031101 ()

  • 96 tests
3110

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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