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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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For the calibration of APOAI and APOB methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445922
In Commercial Distribution

  • 00842768006364 ()
  • 00842768019395 ()
KC720

  • Plasma protein IVD, calibrator
PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445920
In Commercial Distribution

  • 00842768006340 ()
  • 00842768019425 ()
KC716

  • 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 C1 inhibitor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445915
Not in Commercial Distribution

  • 00842768006302 ()
  • 00842768020247 ()
K7086

  • Complement component C1 inhibitor IVD, kit, nephelometry/turbidimetry
For the quantitative measurement of immunoglobulin G subclass 3 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445913
In Commercial Distribution

  • 00842768006289 ()
  • 00842768020209 ()
K7082

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10445716
In Commercial Distribution

  • 00842768003905 ()
  • 00842768019531 ()
B4224-60

  • Multiple coagulation factor IVD, control
Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10445715
In Commercial Distribution

  • 00842768003899 ()
  • 00842768019548 ()
B4224-50

  • Multiple coagulation factor IVD, control
Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445714
In Commercial Distribution

  • 00842768003882 ()
  • 00842768019555 ()
B4219-2

  • Activated partial thromboplastin time (APTT) IVD, reagent
Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445713
In Commercial Distribution

  • 00842768003875 ()
  • 00842768019555 ()
B4219-1

  • Activated partial thromboplastin time (APTT) IVD, reagent
Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445712
In Commercial Distribution

  • 00842768003868 ()
  • 00842768019562 ()
B4218-20

  • Activated partial thromboplastin time (APTT) IVD, reagent
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