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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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Quantitative determination of IgG subclass 2 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446169
In Commercial Distribution

  • 00842768008467 ()
OQXK09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
Quantitative determination of IgG subclass 1 in human serum on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10446168
In Commercial Distribution

  • 00842768008450 ()
OQXI09

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
Washing Solution (concentrate) for cleaning the cuvettes in the BN II System
Siemens Healthcare Diagnostics Products GmbH
10446098
In Commercial Distribution

  • 00842768007781 ()
  • 00842768018992 ()
OQKY61

  • Buffered wash solution IVD
Quantitative determination of IgG subclass 3 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445972
In Commercial Distribution

  • 00842768006708 ()
OPAV03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
For use as an assayed intralaboratory control for assessment of precision and analytical bias in the determination of the hsCRP method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445930
In Commercial Distribution

  • 00842768006432 ()
  • 00842768019326 ()
KC757

  • C-reactive protein (CRP) IVD, control
C1IN CON is an assayed, mid level, intralaboratory quality control for the assessment of precision and analytical bias in the determination of the C1IN method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445927
Not in Commercial Distribution

  • 00842768006418 ()
  • 00842768019340 ()
KC745

  • Plasma protein IVD, control
APO CON is an assayed intralaboratory quality control for the assessment of precision and analytical bias in the determination of APOAI and APOB methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445923
In Commercial Distribution

  • 00842768006371 ()
  • 00842768019388 ()
KC725

  • Plasma protein IVD, control
PROT1 CON L is an assayed, low level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445919
In Commercial Distribution

  • 00842768006333 ()
  • 00842768019432 ()
KC715

  • Plasma protein IVD, control
For the quantitative measurement of a1-microglobulin in human urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445882
Not in Commercial Distribution

  • 00842768005978 ()
  • 00842768019852 ()
K7010

  • Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetry
Sample Cups - Dimension® and Dimension Vista® - 1000 X1.5 mL
Siemens Healthcare Diagnostics Inc.
10445041
In Commercial Distribution

  • 00842768005893 ()
  • 00630414004679 ()
DSC4

  • Assay container IVD, single-use
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