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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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BIOBASE - 06971674860969

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×4 R2:6mL×4
In Commercial Distribution

  • 06971674860969 ()


  • Apolipoprotein B (Apo B) IVD, reagent

BIOBASE - 06971674860952

No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×2 R2:20mL×2
In Commercial Distribution

  • 06971674860952 ()


  • Apolipoprotein B (Apo B) IVD, reagent

IFA B. burgdorferi IgG/IgM Test System - 00845533001656

The ZEUS IFA Borrelia burgdorferi IgG/IgM Test System is designed for the qualitative and semi-quantitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This Test System 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.
FA9351GM
In Commercial Distribution

  • 00845533001656 ()
FA9351GM

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

Trinity Biotech - 05391516746199

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

Trinity Biotech - 05391516746182

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

Trinity Biotech - 05391516748742

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

Trinity Biotech - 05391516748735

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

Elecsys Anti-HBe - 04015630940134

Anti-HBe Elecsys E2G 300
Roche Diagnostics GmbH
07026838190
In Commercial Distribution

  • 04015630940134 ()
07026838190

  • Hepatitis B virus e-antigen/antibody IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg Confirmatory Test - 04015630911110

No Description
Roche Diagnostics GmbH
11820648122
Not in Commercial Distribution

  • 04015630911110 ()
11820648122

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Atellica™ IM HBsII Confirmatory - 00630414599267

HBsAg Confirmatory (HBsII Conf) - Atellica IM - RGT - 98T
Siemens Healthcare Diagnostics Inc.
10995603
In Commercial Distribution

  • 00630414599267 ()
10995603

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
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