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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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No Description
KEOS
23L x 8W x 9H Straight
In Commercial Distribution

  • B084KPS12308090 ()
KPS1-230809

  • Polymeric spinal interbody fusion cage
No Description
KEOS
23L x 8W x 8H Straight
In Commercial Distribution

  • B084KPS12308080 ()
KPS1-230808

  • Polymeric spinal interbody fusion cage
No Description
KEOS
23L x 8W x 7H Straight
In Commercial Distribution

  • B084KPS12308070 ()
KPS1-230807

  • Polymeric spinal interbody fusion cage
No Description
KEOS
23L x 8W x 6H Straight
In Commercial Distribution

  • B084KPS12308060 ()
KPS1-230806

  • Polymeric spinal interbody fusion cage
For the quantitative determination of Alanine Aminotransferase in serum. ALT is widely distributed in tissues with the highest concentrations found in the liver and kidneys. Even so, ALT is considered more liver-specific than AST. Elevated levels of ALT are often only observed in liver diseases such as cirrhosis, hepatitis, or metastatic carcinoma. However, there can be elevated levels of ALT with infectious mononucleosis, muscular dystrophy, and dermatomyositis.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137011862 ()
  • 00812137012227 ()
501-399

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. The Chemistry calibrator is a human based serum. The concentration of the calibrator components have been adjusted to ensure optimal calibration of the CDS methods on specified analyzers. The product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains additives to provide the defined assay values. The concentrations of the calibrator components are lot-specific.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
10 x 5mL, 1 x 50mL
In Commercial Distribution

  • 00812137012111 ()
  • 00812137012401 ()
502-151

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. Total iron-binding capacity (TIBC) is the measure of the ability of serum proteins, principally transferrin, to bind iron. It is the maximum concentration of iron that the serum proteins can bind. Together with the total serum iron concentration, the TIBC is used in the diagnosis and treatment of iron deficiency anemia, other disorders of iron metabolism, and chronic inflammatory disorders. As an index of nutritional status, Serum TIBC is increased in iron deficiency, and decreased in anemia that is due to chronic disease.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 90mL, R2 x 60mL
In Commercial Distribution

  • 00812137012104 ()
  • 00812137012371 ()
501-444

  • Total iron binding capacity IVD (TIBC), reagent
For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only. C-reactive protein (CRP) is an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. As such, CRP is considered to be one of the most sensitive indicators of inflammation.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 50mL, R2 x 50mL
In Commercial Distribution

  • 00812137012098 ()
  • 00812137012364 ()
501-435

  • C-reactive protein (CRP) IVD, reagent
For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Increased levels of LD are associated with myocardial infarction. Levels reach a maximum approximately 48 hours after the onset of pain and persist about ten days. The degree of elevation is of value in assessing the extent of damage and in developing a prognosis. LD elevations are also observed in liver disease, pernicious anemia, in some cases of renal disease, and in some cases of skeletal muscle trauma.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137012005 ()
  • 00812137012333 ()
501-413

  • Lactate dehydrogenase 5 (LDH-5) isoenzyme IVD, reagent
For the quantitative determination of iron in serum. For in vitro diagnostic use only.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011992 ()
  • 00812137012326 ()
501-412

  • Iron IVD, reagent
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