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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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N Latex IgM - 00630414285023

Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873688
In Commercial Distribution

  • 00630414285023 ()
OQAC15

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

N Diluent - 00842768030239

Solution for preparing dilutions for immunochemical determinations with the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10469513
In Commercial Distribution

  • 00842768030239 ()
  • 00842768020261 ()
OUMT05

  • Buffered sample diluent IVD

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 Supplementary Reagent/Precipitation - 00842768011443

Supplementary reagent for multiple protein assays on Siemens systems
Siemens Healthcare Diagnostics Products GmbH
10446458
In Commercial Distribution

  • 00842768011443 ()
OUMU15

  • Buffered isotonic saline reagent IVD

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 Apolipoprotein A-I - 00842768011269

Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446438
In Commercial Distribution

  • 00842768011269 ()
OUED15

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Apolipoprotein A-I - 00842768011252

Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446437
In Commercial Distribution

  • 00842768011252 ()
OUED09

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

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
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