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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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Dimension Vista® ß2-Microglobulin Flex® reagent cartridge - 00842768006043

For the quantitative measurement of ß2-microglobulin in human serum, plasma and urine on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445889
In Commercial Distribution

  • 00842768006043 ()
K7024

  • Beta-2-microglobulin IVD, kit, nephelometry/turbidimetry

Dimension Vista®Antistreptolysin O Flex® reagent cartridge - 00842768006036

For the quantitative measurement of antistreptolysin O in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445888
In Commercial Distribution

  • 00842768006036 ()
  • 00842768019944 ()
K7022

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

Dimension Vista®Apolipoprotein B Flex® reagent cartridge - 00842768006029

For the quantitative measurement of apolipoprotein B in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445887
In Commercial Distribution

  • 00842768006029 ()
  • 00842768019906 ()
K7020

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

Dimension Vista® Apolipoprotein AI Flex® reagent cartridge - 00842768006012

For the quantitative measurement of apolipoprotein A-I in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445886
In Commercial Distribution

  • 00842768006012 ()
  • 00842768019890 ()
K7018

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Dimension Vista®a1-Antitrypsin Flex® reagent cartridge - 00842768005992

For the quantitative measurement of a1-antitrypsin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445884
In Commercial Distribution

  • 00842768005992 ()
  • 00842768019876 ()
K7014

  • Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge - 00842768005985

For the quantitative measurement of a1-acid glycoprotein (Orosomucoid) in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445883
In Commercial Distribution

  • 00842768005985 ()
  • 00842768019869 ()
K7012

  • Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetry

Dimension Vista® a1-Microglobulin Flex® reagent cartridge - 00842768005978

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

Dade® Actin® FSL Activated PTT Reagent - 00842768003882

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

Dade® Actin® FS Activated PTT Reagent - 00842768003868

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

Dade® Actin® FS Activated PTT Reagent - 00842768003844

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445710
In Commercial Distribution

  • 00842768003844 ()
  • 00842768019562 ()
B4218-100

  • Activated partial thromboplastin time (APTT) IVD, reagent
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