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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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Determination of Anti-Streptotysin O (ASL) in human serum and plasma on BN II and BN ProSpec Systems
Siemens Healthcare Diagnostics Products GmbH
10445983
In Commercial Distribution

  • 00842768006791 ()
  • 00842768019258 ()
OPBU03

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Quantitative determination of homocysteine in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445973
In Commercial Distribution

  • 00842768006715 ()
OPAX03

  • Homocysteine IVD, reagent
Quantitative determination of IgG subclass 4 in human serum and plasma on BN II and BN ProSpec® Systems
Siemens Healthcare Diagnostics Products GmbH
10445971
In Commercial Distribution

  • 00842768006692 ()
OPAU03

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
Determination of the functional activity of protein S in human plasma
Siemens Healthcare Diagnostics Products GmbH
10445968
In Commercial Distribution

  • 00842768006678 ()
OPAP03

  • Protein S IVD, kit, clotting
PROT2 CON H is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of ASL, CRP and RF methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445937
In Commercial Distribution

  • 00842768006487 ()
  • 00842768019272 ()
KC787

  • Plasma protein IVD, control
PROT2 CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of ASL, CRP and RF methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445936
In Commercial Distribution

  • 00842768006470 ()
  • 00842768019289 ()
KC785

  • Plasma protein IVD, control
For the calibration of the A1MIC, CYSC, MALB and sALB (for serum, plasma and cerebrospinal fluid) methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445931
In Commercial Distribution

  • 00842768006449 ()
  • 00842768019319 ()
KC770

  • Plasma protein IVD, calibrator
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
10445929
In Commercial Distribution

  • 00842768006425 ()
  • 00842768019333 ()
KC755

  • C-reactive protein (CRP) IVD, control
CYSC CON H is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445925
In Commercial Distribution

  • 00842768006395 ()
  • 00842768019364 ()
KC737

  • Plasma protein IVD, control
CYSC CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445924
In Commercial Distribution

  • 00842768006388 ()
  • 00842768019371 ()
KC735

  • Plasma protein IVD, control
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