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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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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

N Diluent - 00842768011436

Solution for preparing dilutions for immunochemical determinations with the Siemens Systems
Siemens Healthcare Diagnostics Products GmbH
10446457
In Commercial Distribution

  • 00842768011436 ()
OUMT65

  • Buffered sample diluent IVD

N Antiserum to Human Plasminogen - 00842768009952

Quantitative determination of plasminogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446314
In Commercial Distribution

  • 00842768009952 ()
OSCB09

  • Plasminogen IVD, reagent

N Antiserum to Human Fibrinogen - 00842768009945

Quantitative determination of fibrinogen in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446313
In Commercial Distribution

  • 00842768009945 ()
OSCA09

  • Fibrinogen assay (factor I) IVD, kit, clotting

N Antiserum to Human Antithrombin III - 00842768009914

Quantitative determination of antithrombin III in human plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446310
In Commercial Distribution

  • 00842768009914 ()
OSAY09

  • Antithrombin III (ATIII) IVD, reagent

N Antiserum to Human a1-acid Glycoprotein - 00842768009884

Quantitative determination of a1-acid glycoprotein in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446307
In Commercial Distribution

  • 00842768009884 ()
OSAW15

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry
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