AbTrol ClinChem Controls


In Vitro Test Materials

Intended use:
The AbTrol ClinChem Control Set is intended to be used as unassayed quality control material for laboratory test procedures for the analytes listed.

Description:
Name Quantity Ready to Use (1) Lyophilized (2)
AbTrol ClinChem Control Low 5 mL 2130053 2130087
AbTrol ClinChem Control Medium 5 mL 2130054 2130088
AbTrol ClinChem Control High 5 mL 2130057 2130089
AbTrol ClinChem Control Set 2 x 3 Level 2130072 2130086
(1) For Investigational Use Only. The performance characteristics of this product have not been established.
(2) In Vitro Diagnostic Product

Stability
Unopened Vial: Twenty four months when stored at recommended storage conditions.
Open/Reconstituted Vial: 30 days when stored at 2 - 8 o C.

Each control contains human serum, purified biochemical materials, chemicals, and < 0.1% sodium azide as preservative.

Results:
The AbTrol ClinChem Control Set is used to verify the correct functioning of laboratory tests and the analyzers used to perform them for the analytes listed below. These values are provided solely for the convenience of the evaluator prior to the assessment of the control.

Typical Values

Analyte Low Med High Units
Albumin 2.7 3.5 4.4 g/dL
Alkaline Phosphatase 55 200 350 U/L
ALT/SGPT 1.8 60 105 U/L
Amylase 50 250 450 U/L
AST/SGOT 55 175 300 U/L
Bilirubin (Direct) 0.5 1.6 2.7 mg/dL
Bilirubin (Total) 0.7 2.0 3.2 mg/dL
Calcium 5.8 7.8 11.0 mg/dL
Chloride 78 100 122 mEq/L
Cholesterol 100 160 250 mg/dL
CK (Creatine Kinase) 78 250 425 U/L
Creatinine 1.0 2.8 5.0 mg/dL
GGT 33 110 180 U/L
Glucose 80 150 230 mg/dL
Iron 60 140 250 ug/dL
LDH (Lactate Dehydrogenase) 78 250 425 U/L
Magnesium 1.0 2.5 4.3 mg/dL
Phosphorous 1.8 4.8 7.0 mg/dL
Potassium 1.8 4.8 7.0 mEq/L
Sodium 108 128 150 mEq/L
Total Protein 4.8 6.2 7,8 g/dL
Triglycerides 45 105 190 mg/dL
Urea Nitrogen 15 30 45 mg/dL
Uric Acid 2.5 5.0 7.5 mg/dL



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