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 Class Implantable

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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 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
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
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
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
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 use in daily maintenance of the IMMULITE® and IMMULITE® 1000 systems
Siemens Healthcare Diagnostics Products GmbH
10385332
In Commercial Distribution

  • 00842768028441 ()
LKPM

  • Wash/cleaning solution IVD, automated/semi-automated system
For use in daily maintenance of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385229
In Commercial Distribution

  • 00842768028434 ()
L2KPM

  • Wash/cleaning solution IVD, automated/semi-automated system
For use in the routine operation of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers
Siemens Healthcare Diagnostics Products GmbH
10385231
In Commercial Distribution

  • 00842768028427 ()
  • 00842768019708 ()
L2PWSM

  • Wash/cleaning solution IVD, automated/semi-automated system
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