MAGLUMI Anti-SS-B IgG (CLIA)

Snibe MAGLUMI EBV EA IgA (CLIA) Condition : New Usage Type : In vitro diagnostic use Use : Detection of EpsteinBarr Virus (EBV) Early Antigen IgA in human serum or plasma Portable : Yes Equipment Type : Immunoassay Reagent Kit Real-Time Operation : Yes Wall Mounted : No Storage Instructions : Store at 28C, protected from light Technology : Chemiluminescent Immunoassay (CLIA) Operating Type : Other, Automated Measurement Range : Qualitative detection of EBV EA IgA Power Source : Other, Requires compatible immunoassay analyzer Accuracy : 98% (based on manufacturer data) Function : Detection of EBV early antigen IgA antibodies Shelf Life : 12 months from manufacturing Instruments Type : Compatible with Snibe MAGLUMI analyzers Material : Other, Diagnostic grade chemicals (for CLIA) Features : High sensitivity and specificity; Readytouse reagents; Calibrators and controls included Dimension (L*W*H) : Kit packaging dimensions vary Color : White/Blue kit vials Weight : Approx 0.51 kg per kit Voltage : Depends on analyzer Power Consumption : Depends on analyzer Frequency : Single test per sample Noise Level : Negligible

Snibe MAGLUMI Vitamin B12 (CLIA) Condition : New Usage Type : Invitro Diagnostic Use Only Use : Quantitative Detection of Vitamin B12 in Human Serum/Plasma Portable : No Equipment Type : Vitamin B12 Analyzer Reagent Kit Real-Time Operation : Yes Wall Mounted : No Storage Instructions : Store at 28C Technology : Chemiluminescent Immunoassay (CLIA) Measurement Range : 502000 pg/mL Power Source : Other Accuracy : 95% (as per manufacturer data) Function : Vitamin B12 Quantification Shelf Life : 12 Months Instruments Type : Reagent Kit for MAGLUMI CLIA Series Material : Other Features : High Sensitivity, Specificity, Rapid Results, Traceable Calibration, Reproducible Dimension (L*W*H) : Not Applicable (Reagent Bottles) Color : White (Reagent Bottles) Weight : Not Applicable (Reagent Kit) Voltage : Depends on Analyzer Power Consumption : Depends on Analyzer Frequency : Depends on Instrument Protocol Noise Level : Low/Negligible

Snibe MAGLUMI CYFRA 21-1 (CLIA) Condition : New Usage Type : Laboratory Use Only Use : Quantitative Determination of CYFRA 211 in Human Serum or Plasma Portable : No (Requires MAGLUMI Analyzer) Equipment Type : Immunoassay Analyzer Reagent Real-Time Operation : Yes Wall Mounted : No Storage Instructions : Store at 28C, Protect from Light Technology : Chemiluminescence Immunoassay (CLIA) Operating Type : Other, Automatic (For use with MAGLUMI Series) Measurement Range : 0.1 ng/mL 100 ng/mL Power Source : Other, Not Applicable (Reagent Kit) Accuracy : High, as per Manufacturer Validation Function : Tumor Marker Detection (CYFRA 211) Shelf Life : 12 months (unopened at 28C) Instruments Type : MAGLUMI Automated Immunoassay Analyzer Material : Other, Diagnostic Reagent Kit Features : High Sensitivity, High Specificity, For MAGLUMI CLIA Systems Dimension (L*W*H) : Box Packaging, Standard Kit Size Color : Colorless/Transparent (Reagent Solutions) Weight : Approx. 1 kg (Kit)

Snibe MAGLUMI Ferritin (CLIA) Condition : New Usage Type : Hospital, Pathology Laboratory, Clinical Diagnostics Use : Quantitative determination of Ferritin in human serum and plasma Portable : No Equipment Type : Fully Automated Immunoassay Analyzer Reagent (CLIA) Real-Time Operation : Yes Wall Mounted : No Storage Instructions : 28C, protected from light Technology : Chemiluminescence Immunoassay (CLIA) Operating Type : Other, Automated Measurement Range : 0.51500 ng/mL Power Source : Other, Not Applicable (used with analyzer) Accuracy : Within manufacturer specifications: typically CV 5% in normal range Function : Quantitative Ferritin measurement in serum or plasma Shelf Life : 12 months Instruments Type : MAGLUMI Immunoassay System Material : Other, Reagents, Antibodycoated Magnetic Microbeads, Enzyme Conjugate Features : High sensitivity, Wide measuring range, Fast assay time, Automated processing, Traceable to reference standards