MAGLUMI IA 2 (CLIA)

Snibe MAGLUMI Total PSA (CLIA) Condition : New Technology : Chemiluminescent Immunoassay (CLIA) Real-Time Operation : Yes Usage Type : Professional Equipment Type : Immunoassay Analyzer (CLIA) Storage Instructions : 28C, keep away from sunlight Instruments Type : Compatible with MAGLUMI series analyzers Use : Clinical Laboratory PSA Testing Function : Quantitative measurement of Total PSA in human serum Features : High throughput, Fast results, Accurate PSA quantification Accuracy : CV<10% (withinrun precision) Weight : Instrumentdependent (refer to analyzer specification) Measurement Range : 0.2100 ng/mL (varies by kit/analyzer) Dimension (L*W*H) : Instrumentdependent (refer to analyzer specification) Wall Mounted : No Portable : No Display Type : Digital Display (on compatible analyzers) Power Source : Electric Power Consumption : Approx. 100240V AC, 50/60 Hz Voltage : 100240V Shelf Life : 12 months Operating Type : Other, Fully Automated Color : White Frequency : Instrumentdependent Material : Other, Diagnostic Reagent

Snibe MAGLUMI CA 15-3 (CLIA) Condition : New Technology : Chemiluminescence Immunoassay (CLIA) Real-Time Operation : Other, Yes (Applicable with compatible analyzer) Usage Type : Laboratory Diagnostic Equipment Type : Immunoassay Analyzer Reagent Kit Storage Instructions : 28C, protected from light Instruments Type : For use with MAGLUMI series analyzers Use : Quantitative determination of CA 153 in human serum or plasma Function : Quantitative measurement of tumor marker CA 153 Features : High sensitivity, Specific for CA 153, Compatible with MAGLUMI analyzers, Readytouse reagents Accuracy : High (analyzer and standard curve dependent) Weight : Not Applicable (kit only) Measurement Range : 1.0300.0 U/mL (assay specific) Dimension (L*W*H) : Not Applicable (reagent kit only) Wall Mounted : No Portable : No Display Type : Not Applicable (analyzer dependent) Power Source : Other, Analyzer powered (external electric supply required for instrument) Power Consumption : Not Applicable (analyzer dependent) Voltage : Not Applicable (analyzer dependent) Shelf Life : 12 months Operating Type : Other, Automated/Instrumentbased Color : Colorless to light yellow, as per reagent formulation Frequency : Not Applicable (reagent kit only) Material : Other, Liquid reagents, plastic cartridges

Snibe MAGLUMI FSH (CLIA) Condition : New Technology : Chemiluminescence Immunoassay (CLIA) Real-Time Operation : Yes Usage Type : Single Use Reagent Kit Equipment Type : Immunoassay Analyzer Reagent Storage Instructions : Store at 28C. Do not freeze. Instruments Type : Automated Immunoassay System (for use with MAGLUMI analyzers) Use : For quantitative determination of FSH in human serum or plasma Function : Detection & Quantification of Follicle Stimulating Hormone (FSH) Features : High sensitivity and specificity; readytouse reagents; automated processing Accuracy : High accuracy, as per manufacturers insert (typically CV <10%) Weight : Depends on Kit Size (typically <1 kg per kit) Measurement Range : 0.1200 mIU/mL (refer to IFU for exact range) Dimension (L*W*H) : Reagent Vials Standard Size (Varies with pack) Wall Mounted : No Portable : Laboratory Use, Not Portable Display Type : Dependent on analyzer (digital display) Power Source : Other, Analyzer Driven (Electricity) Power Consumption : Dependent on analyzer model Voltage : Dependent on analyzer model Shelf Life : 12 months from date of manufacture Operating Type : Other, Automatic with compatible analyzer Color : Colorless to light yellow liquid Frequency : Dependent on analyzer protocol Material : Other, Diagnostic Grade Reagents and Consumables

MAGLUMI EBV EA IgG (CLIA) Minimum Order Quantity : 1 Condition : New Technology : chemiluminescence immunoassay Real-Time Operation : Yes Usage Type : Laboratory Equipment Type : For use with MAGLUMI CLIA analyzers Storage Instructions : 2 to 8 degree Instruments Type : CLIA