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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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Audit MicroControls Control LQ COVID-19 IgG + IgM Antibodies - B085K087M60

No Description
AALTO SCIENTIFIC
K087M-6
In Commercial Distribution

  • B085K087M60 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control

Audit MicroControls Control LQ COVID-19 Antibodies - B085K077M60

No Description
AALTO SCIENTIFIC
K077M-6
In Commercial Distribution

  • B085K077M60 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, control

IMMY - 00816387020797

ID Candida Antibody System
Immuno-Mycologics, Inc.
CA1001
In Commercial Distribution

  • 00816387020797 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent

IMMY - 00816387020230

Candida ID Positive Control
Immuno-Mycologics, Inc.
C60110
In Commercial Distribution

  • 00816387020230 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent

IMMY - 00816387020223

Candida ID Antigen
Immuno-Mycologics, Inc.
C50110
In Commercial Distribution

  • 00816387020223 ()


  • Candida albicans immunoglobulin G (IgG)/IgM antibody IVD, reagent

Legionella pneumophila IgG ELISA - 04048474056457

The Legionella pneumophila IgG ELISA is intended for the qualitative determination of IgG class antibodies against Legionella pneumophila in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-5645
In Commercial Distribution

  • 04048474056457 ()
EIA-5645

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

EliA SARS-CoV-2-Sp1 IgG Well - 07333066021287

EliA SARS-CoV-2-Sp1 IgG Well
Phadia AB
DECC066630
In Commercial Distribution

  • 07333066021201 ()
  • 07333066021287 ()
DECC066630

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Optilite IgA CSF Kit - 05051700020190

No Description
THE BINDING SITE GROUP LIMITED
LK010.L.OPT.A
In Commercial Distribution

  • 05051700020190 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Optilite IgM CSF Kit - 05051700020183

No Description
THE BINDING SITE GROUP LIMITED
LK012.L.OPT.A
In Commercial Distribution

  • 05051700020183 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

N Reaction Buffer - 00842768014246

Reaction medium for immunochemical determination with the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446455
In Commercial Distribution

  • 00842768014246 ()
OUMS65

  • Multiple clinical chemistry protein IVD, reagent
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