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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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The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution

  • 00812137012067 ()
  • 00812137012319 ()
501-419

  • High density lipoprotein (HDL) cholesterol IVD, reagent
This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Throughout the circulatory life of the red cell, Hemoglobin A1c is formed continuously by the adduction of glucose to the N-terminal of the hemoglobin beta chain. This process, which is non-enzymatic, reflects the average exposure of hemoglobin to glucose over an extended period.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
L1 x 2 x 0.5mL, L2 x 2 x 0.5mL
In Commercial Distribution

  • 00812137012166 ()
  • 00812137012449 ()
502-156

  • Glycated haemoglobin (HbA1c) IVD, control
The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 70mL, R2 x 1 x 50mL
In Commercial Distribution

  • 00812137012074 ()
  • 00812137012340 ()
501-420

  • Dense low density lipoprotein (DLDL) cholesterol IVD, kit, mass spectrometry
For the quantitative determination of magnesium in serum. For in vitro diagnostic use only. Magnesium in the body is found primarily in bone with some in soft tissue, blood cells, and serum. Decreased levels have been observed in cases of diabetes, alcoholism, diuretics, hyperthyroidism, hypothyroidism, malabsorption, hyperalimenation, myocardial infarction, congestive heart failure and liver cirrhosis. Increased serum magnesium levels have been found in renal failure, diabetic acidosis, Addison’s disease, and vitamin D intoxication.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 2 x 120mL, R2 x 2 x 120mL
In Commercial Distribution

  • 00812137012012 ()
  • 00812137012364 ()
501-414

  • Magnesium (Mg2+) IVD, reagent
Dermisplus Prevent Strip 20 x 1 x 0.1in (pk of 5)
Frontier Therapeutics Inc
8500001
In Commercial Distribution

  • 05056279304108 ()


  • Pressure-management bandage, silicone
Dermisplus Prevent Strip 12 x 2 x 0.1in (pk of 5)
Frontier Therapeutics Inc
8500006
In Commercial Distribution

  • 05056279304092 ()


  • Pressure-management bandage, silicone
Dermisplus Prevent Pad 8 x 8 x 0.5in (Pk of 2)
Frontier Therapeutics Inc
8500009
In Commercial Distribution

  • 05056279304085 ()


  • Pressure-management bandage, silicone
Dermisplus Prevent Pad 8 x 8 x 0.1in (pk of 2)
Frontier Therapeutics Inc
8500005
In Commercial Distribution

  • 05056279304078 ()


  • Pressure-management bandage, silicone
Dermisplus Prevent Pad 4 x 4 x 0.5in (pk of 5)
Frontier Therapeutics Inc
8500003
In Commercial Distribution

  • 05056279304061 ()


  • Pressure-management bandage, silicone
Dermisplus Prevent Pad 4 x 4 x 0.1in (pk of 5)
Frontier Therapeutics Inc
8500007
In Commercial Distribution

  • 05056279304054 ()


  • Pressure-management bandage, silicone
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