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

  • 04015630940134 ()
07026838190

  • Hepatitis B virus e-antigen/antibody IVD, kit, chemiluminescent immunoassay
HBsAg Confirmatory Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374036
Not in Commercial Distribution

  • 00630414971544 ()
LKCH(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
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
HBsAg Conf (Confirmatory) Assay Kit
Siemens Healthcare Diagnostics Inc.
10309058
In Commercial Distribution

  • 00630414472874 ()
3393818

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
HBsAg Confirmatory Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706825
In Commercial Distribution

  • 00630414947433 ()
L2KCH1(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11820648122
Not in Commercial Distribution

  • 04015630911110 ()
11820648122

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
HBsAg Confirmatory Test Elecsys cobas e V2
Roche Diagnostics GmbH
09127127190
In Commercial Distribution

  • 07613336175293 ()
09127127190

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