MAGLUMI Anti-HBc IgM (CLIA)

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

Snibe MAGLUMI TPA (CLIA) Condition : New Usage Type : Diagnostic Laboratory Use Storage Instructions : Store at 28C, protect from light Technology : Chemiluminescent Immunoassay (CLIA) Real-Time Operation : Yes Equipment Type : Automated Chemiluminescence Immunoassay Analyzer (CLIA) Reagent Kit Instruments Type : For use on Snibe MAGLUMI Series Automated Immunoassay Analyzers Shelf Life : 12 months from manufacturing date Features : High sensitivity and specificity, Fully automated processing, Fast and accurate results, Compatible with Snibe MAGLUMI analyzers Accuracy : Meets clinical laboratory standards Function : TPA (Tissue Polypeptide Antigen) detection Wall Mounted : No Color : Clear/White Reagent Vials Operating Type : Other, Automated Portable : Yes (Reagent Kit) Material : Other, Plastic Vials, Reagent Solution Use : Quantitative detection of Tissue Polypeptide Antigen (TPA) in human serum or plasma Measurement Range : The measuring range is up to 500 U/L (refer to kit insert for details) Power Source : Other, Not Applicable (Reagent Kit) Weight : Kit weight varies by volume/package Dimension (L*W*H) : Box dimensions vary by kit size

Snibe MAGLUMI SCCA (CLIA) Condition : New Usage Type : Diagnostic/Reagent Storage Instructions : 28C; Protect from light Technology : Chemiluminescence Immunoassay (CLIA) Real-Time Operation : Yes Equipment Type : Immunochemistry Analyzer Reagent (SCCA Assay) Instruments Type : Clinical Chemistry Immunoassay System Shelf Life : 12 Months Features : High sensitivity; specificity; compatible with MAGLUMI analyzers Accuracy : High (per analyzer calibration) Function : Detection of SCCA biomarker Wall Mounted : No Color : Transparent/Liquid Operating Type : Other, Automated Portable : No (used with MAGLUMI system) Material : Other, Liquid Reagent (for clinical analysis) Use : Quantitative determination of Squamous Cell Carcinoma Antigen (SCCA) in human serum or plasma Measurement Range : 0.1150 ng/mL Power Source : Other, Not Applicable (used with analyzer system)

Snibe MAGLUMI Albumin (CLIA) Condition : New Usage Type : Laboratory Use Storage Instructions : Store at 28C Technology : Chemiluminescent Immunoassay (CLIA) Real-Time Operation : Yes Equipment Type : CLIA Reagent Kit Instruments Type : Compatible with MAGLUMI Immunoassay Analyzers Shelf Life : 12 months Features : High sensitivity, automated workflow, accurate and reliable results Accuracy : High accuracy, depends on analyzer performance Function : Determination of albumin concentration Wall Mounted : No Color : White / Transparent (as per reagent vials) Operating Type : Other, Automated Portable : No Material : Other, Diagnostic Reagent Use : Quantitative determination of Albumin in human serum or plasma Measurement Range : Varies per kit (refer to IFU); typically covers clinical albumin range