MAGLUMI Cholylglycine (CLIA)

Snibe MAGLUMI S-100 (CLIA) Condition : New Usage Type : Laboratory, Hospital, Diagnostic Center Storage Instructions : Keep in a cool, dry place Equipment Type : Chemiluminescence Immunoassay Analyzer Real-Time Operation : Yes Technology : CLIA (Chemiluminescence Immunoassay) Instruments Type : Fully Automated Accuracy : High analytical sensitivity and specificity Color : White and Blue Wall Mounted : No Function : Quantitative immunoassay analyzer Measurement Range : Wide, depending on reagent Operating Type : Automatic Material : Other, ABS Plastic, Stainless Steel Use : Invitro diagnostics, Clinical laboratory testing Portable : No Features : High throughput, Compact design, Random access, STAT function, Userfriendly interface Power Source : Electric Dimension (L*W*H) : 700 470 510 mm Power Consumption : 300 VA Weight : 45 kg (approx.) Display Type : LCD Touchscreen Frequency : 50/60 Hz Voltage : AC 100240V, 50/60 Hz

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

Snibe MAGLUMI CRP (CLIA) Condition : New Usage Type : Laboratory Storage Instructions : Store at 28C Equipment Type : Chemiluminescence Immunoassay (CLIA) Analyzer Reagent Real-Time Operation : Yes Technology : Chemiluminescence Immunoassay (CLIA) Instruments Type : Automatic Chemiluminescence Analyzer Reagent Accuracy : High (as per manufacturers validation) Color : Colorless/Transparent Reagent, as per standard Wall Mounted : No Function : Measurement of CRP concentration as an acutephase inflammation marker Measurement Range : 0.5320 mg/L (may vary by lot and instrument) Operating Type : Other, Automated Material : Other, Invitro Diagnostic Kit (Reagent) Use : For quantitative determination of CReactive Protein (CRP) in human serum and plasma Portable : No Features : High sensitivity, High specificity, Compatible with MAGLUMI Immunoassay System Shelf Life : 12 months Power Source : Other, Not Applicable (Analyzer Powered) Dimension (L*W*H) : Not Applicable (Reagent Vials)

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