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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® Apolipoprotein Control - 00842768006371

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

DImension Vista® Protein 1 Control M (medium) - 00842768006340

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

DImension Vista® Protein 1 Control L (low) - 00842768006333

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

DImension Vista® Retinol binding Protein - 00842768006227

For the quantitative measurement of retinol binding protein in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445907
Not in Commercial Distribution

  • 00842768006227 ()
  • 00842768020148 ()
K7066

  • Retinol binding protein IVD, kit, nephelometry/turbidimetry

DImension Vista® Prealbumin Flex® reagent cartridge - 00842768006210

For the quantitative measurement of Prealbumin in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445906
In Commercial Distribution

  • 00842768006210 ()
  • 00842768020131 ()
K7064

  • Collagen pyridium crosslink IVD, reagent

Dimension® Flex® reagent cartridge CHOL - 00842768005466

Cholesterol Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444891
In Commercial Distribution

  • 00842768005466 ()
  • 00630414003849 ()
DF27

  • Total cholesterol lipid IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge LA - 00842768005398

Lactic Acid Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444961
In Commercial Distribution

  • 00842768005398 ()
  • 00630414004440 ()
DF16

  • Lactate IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge ALDL - 00842768005350

Automated LDL Cholesterol Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444890
In Commercial Distribution

  • 00842768005350 ()
  • 00630414003832 ()
DF131

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

Dimension® DOA-Negative Control - 00842768005145

Drugs of Abuse Negative Control, 6x5mL
Siemens Healthcare Diagnostics Inc.
10445032
In Commercial Distribution

  • 00842768005145 ()
  • 00630414004624 ()
DC44A

  • Multiple drugs of abuse IVD, control

Dimension® DOA-Positive Control - 00842768005138

Drugs of Abuse Positive Control, 6x5mL
Siemens Healthcare Diagnostics Inc.
10445033
In Commercial Distribution

  • 00842768005138 ()
  • 00630414004631 ()
DC43A

  • Multiple drugs of abuse IVD, control
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