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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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Urea Nitrogen Reagent Set - 00812137011916

For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Determination of urea nitrogen in serum is widely used as a screening test for renal function. When used in conjunction with the determination of creatinine in serum it is helpful in the differential diagnosis of the three types of azotemia; pre-renal, renal and post-renal.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 125mL
In Commercial Distribution

  • 00812137011916 ()
  • 00812137012272 ()
501-404

  • Urea IVD, kit, enzyme spectrophotometry

Total Bilirubin Reagent Set - 00812137011909

For the quantitative determination of total bilirubin in serum.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011909 ()
  • 00812137012265 ()
501-403

  • Total bilirubin IVD, kit, enzyme spectrophotometry

Direct Bilirubin Reagent Set - 00812137011893

For the quantitative determination of direct bilirubin in serum.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011893 ()
  • 00812137012258 ()
501-402

  • Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry

ALT (SGPT) Reagent Set - 00812137011862

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

Henry Schein - 10304040108786

Dental syringe, 6cc Luer Lock Non sterile
HENRY SCHEIN, INC.
5701403
In Commercial Distribution

  • 20304040108783 ()
  • 10304040108786 ()
  • 00304040108789 ()
5701403

  • Anaesthesia Luer syringe, non-sterile

Henry Schein - 10304040108762

Dental syringe Luer Lock 12 cc Non sterile
HENRY SCHEIN, INC.
5701401
In Commercial Distribution

  • 20304040108769 ()
  • 10304040108762 ()
  • 00304040108765 ()
5701401

  • Anaesthesia Luer syringe, non-sterile

Henry Schein - 10304040108755

Dentals syringe, 3cc Luer Lock Non sterile
HENRY SCHEIN, INC.
5701400
In Commercial Distribution

  • 20304040108752 ()
  • 10304040108755 ()
  • 00304040108758 ()
5701400

  • Anaesthesia Luer syringe, non-sterile

HENRY SCHEIN - 10304040103989

Tray Barrier 10.5x14
HENRY SCHEIN, INC.
5701321
In Commercial Distribution

  • 20304040103986 ()
  • 10304040103989 ()
  • 00304040103982 ()
5701321

  • Medical equipment drape, single-use, non-sterile

HENRY SCHEIN - 10304040103910

X Ray COVER 15x26
HENRY SCHEIN, INC.
5701319
In Commercial Distribution

  • 20304040103917 ()
  • 10304040103910 ()
  • 00304040103913 ()
5701319

  • Medical equipment drape, single-use, non-sterile

HENRY SCHEIN - 10304040103903

Cover Film Blue 4x6
HENRY SCHEIN, INC.
5701318
In Commercial Distribution

  • 20304040103900 ()
  • 10304040103903 ()
  • 00304040103906 ()
5701318

  • Medical equipment drape, single-use, non-sterile
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