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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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Fungal Serology - 10634853000015

Blastomyces dermatitidis Antigen (A), 1mL
MICROBIOLOGICS INC.
200125
Not in Commercial Distribution

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control

N/A - 00382903492091

BD® CD19 (4G7) PE
Becton, Dickinson And Company
349209
In Commercial Distribution

  • 00382903492091 ()
349209

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

Bordetella Pertussis IgG - 07290016332636

Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
SAVYON DIAGNOSTICS LTD
A2231-01M
In Commercial Distribution

  • 07290016332636 ()
A2231-01M

  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

ETI-EBK PLUS - 08056771102353

No Description
DIASORIN SPA
P001930
In Commercial Distribution

  • 08056771102353 ()


  • Hepatitis B virus e-antigen IVD, kit, enzyme immunoassay (EIA)

LIAISON XL MUREX HBsAg Qual - 08056771500180

No Description
DIASORIN S.P.A.
318250
In Commercial Distribution

  • 18056771500187 ()
  • 08056771500180 ()


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

ABBOTT PRISM - 00380740062989

ABBOTT PRISM HBsAg Assay Kit
ABBOTT LABORATORIES
6D19-68
Not in Commercial Distribution

  • 00380740062989 ()
06D1968

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

ABBOTT PRISM - 00380740062972

ABBOTT PRISM HBsAg Confirmatory Assay Kit
ABBOTT LABORATORIES
6E51-68
Not in Commercial Distribution

  • 00380740062972 ()
06E5168

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

Alinity - 00380740136819

Alinity s HBsAg Reagent Kit
Abbott Ireland Diagnostics
06P0260
In Commercial Distribution

  • 00380740136819 ()
06P0260

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

Alinity - 00380740136789

Alinity s HBsAg Confirmatory Reagent Kit
Abbott Ireland Diagnostics
06P0359
In Commercial Distribution

  • 00380740136789 ()
06P0359

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

D3 Ultra - 30014613330417

Influenza B DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013202.V2
In Commercial Distribution

  • 30014613330417 ()
01-013202.V2

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay
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