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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® Sample Diluent - 00842768000119

Sample Diluent, 2 bottles, 50 mL per bottle
Siemens Healthcare Diagnostics Inc.
10444875
In Commercial Distribution

  • 00842768000119 ()
  • 00630414016948 ()
791092901

  • Buffered sample diluent IVD

Dimension® Dimension Vista® System Enzyme Diluent - 00842768000102

Enzyme Diluent, 10x10mL
Siemens Healthcare Diagnostics Inc.
10444870
In Commercial Distribution

  • 00842768000102 ()
  • 00630414003771 ()
790035901

  • Buffered sample diluent IVD

FlexiOH - 08908014765002

FlexiOH Short Arm Immobilizer is indicated for Distal radius stable fracture , wrist fracture and wrist sprain.
JC ORTHOHEAL PRIVATE LIMITED
Short Arm Immobilizer XXS
Not in Commercial Distribution

  • 08908014765002 ()

  • XXS


  • Hand orthosis

INNOVANCE Free PS Ag - 00842768039522

For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer.
Siemens Healthcare Diagnostics Products GmbH
10873458
In Commercial Distribution

  • 00842768039522 ()
OPGL07

  • Protein S IVD, kit, nephelometry/turbidimetry

Dade® CA System Buffer - 00842768039416

For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873440
In Commercial Distribution

  • 00842768039416 ()
  • 00842768019845 ()
B4265-37

  • Buffered sample diluent IVD

Dimension Vista® ALPI CAL - 00842768039041

Alkaline Phosphatase Calibrator, 3 x 1mL
Siemens Healthcare Diagnostics Inc.
10714029
In Commercial Distribution

  • 00842768039041 ()
KC331

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator

Dimension Vista® Flex® reagent cartridge ALPI - 00842768039034

Alkaline Phosphatase Flex® reagent cartridge, 1600 tests
Siemens Healthcare Diagnostics Inc.
10642444
In Commercial Distribution

  • 00842768039034 ()
  • 00630414005942 ()
K2115

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Dimension® ALPI CAL - 00842768039027

Alkaline Phosphatase calibrator, 3x2x1mL
Siemens Healthcare Diagnostics Inc.
10714028
In Commercial Distribution

  • 00842768039027 ()
DC150

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator

Dimension® Flex® reagent cartridge ALPI - 00842768039010

Alkaline Phosphatase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10642445
In Commercial Distribution

  • 00842768039010 ()
  • 00630414005959 ()
DF150

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

BC von Willebrand Reagent - 00842768038211

Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
Siemens Healthcare Diagnostics Products GmbH
10714565
In Commercial Distribution

  • 00842768038211 ()
  • 00842768018800 ()
OUBD39

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
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