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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 Antisera to Human IgM - 00842768009822

Quantitative determination of IgM in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446301
In Commercial Distribution

  • 00842768009822 ()
OSAT11

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

N Antisera to Human IgA - 00842768009761

Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446295
In Commercial Distribution

  • 00842768009761 ()
OSAR19

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

N Antisera to Human IgA - 00842768009747

Quantitative determination of IgA in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446293
In Commercial Distribution

  • 00842768009747 ()
OSAR11

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

N Antiserum to Human Apolipoprotein B - 00842768009686

Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446287
In Commercial Distribution

  • 00842768009686 ()
OSAN15

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Apolipoprotein B - 00842768009679

Quantitative determination of apolipoprotein B in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446286
In Commercial Distribution

  • 00842768009679 ()
OSAN09

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry

N Latex IgM - 00842768007194

Quantitative determination of IgM in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446035
In Commercial Distribution

  • 00842768007194 ()
OQAC11

  • 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 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

DImension Vista® Immunoglobulin M Flex® reagent cartridge - 00842768006197

For the quantitative measurement of immunoglobulin M in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445904
In Commercial Distribution

  • 00842768006197 ()
  • 00842768020100 ()
K7058

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

DImension Vista® Immunoglobulin A Flex® reagent cartridge - 00842768006166

For the quantitative measurement of immunoglobulin A in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445901
In Commercial Distribution

  • 00842768006166 ()
  • 00842768020070 ()
K7052

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