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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 2320-1010 G
Not in Commercial Distribution

  • 04049016055648 ()


  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2320-1005 G
Not in Commercial Distribution

  • 04049016055631 ()


  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2320-1003 G
Not in Commercial Distribution

  • 04049016055624 ()


  • Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
PLATELIA Lyme IgG
BIO-RAD
25297
Not in Commercial Distribution

  • 03610520007877 ()
25297

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
IB0901
In Commercial Distribution

  • 10816101021014 ()
IB0901

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, reagent
The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical finding to provide serological evidence of infection with T. pallidum. This test is for In Vitro diagnostic use only . This test is not intended for screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
SM3Z7611G
In Commercial Distribution

  • 00845533001168 ()
SM3Z7611G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical finding to provide serological evidence of infection with T. pallidum. This test is for In Vitro diagnostic use only . This test is not intended for screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
3Z7611G
In Commercial Distribution

  • 00845533001151 ()
3Z7611G

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Borrelia burgdorferi IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgG antibodies to Borrelia burgdorferi in human serum. This test should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
SM3Z9651G
In Commercial Distribution

  • 00845533000185 ()
SM3Z9651G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Borrelia burgdorferi IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of IgG antibodies to Borrelia burgdorferi in human serum. This test should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
ZEUS SCIENTIFIC, INC.
3Z9651G
In Commercial Distribution

  • 00845533000178 ()
3Z9651G

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3830
In Commercial Distribution

  • 04048474038309 ()
EIA-3830

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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