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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
Biobase Biodustry(Shandong)Co., Ltd.
R1:90mL×1 R2:30mL×1
In Commercial Distribution

  • 06971674861034 ()


  • Apolipoprotein B (Apo B) IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×4 R2:6mL×4
In Commercial Distribution

  • 06971674861027 ()


  • Apolipoprotein B (Apo B) IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×2 R2:20mL×2
In Commercial Distribution

  • 06971674861010 ()


  • Apolipoprotein B (Apo B) IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:48mL×2 R2:16mL×2
In Commercial Distribution

  • 06971674861003 ()


  • Apolipoprotein B (Apo B) IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:40mL×3 R2:20mL×2
In Commercial Distribution

  • 06971674860990 ()


  • Apolipoprotein B (Apo B) IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×1 R2:20mL×1
In Commercial Distribution

  • 06971674860983 ()


  • Apolipoprotein B (Apo B) IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×1 R2:6mL×1
In Commercial Distribution

  • 06971674860976 ()


  • Apolipoprotein B (Apo B) IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×2 R2:20mL×2
In Commercial Distribution

  • 06971674860952 ()


  • Apolipoprotein B (Apo B) IVD, reagent
EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Borrelia afzelii “PKO” and Borrelia garinii, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020M
In Commercial Distribution

  • 05391516748742 ()
44-2020M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
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
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