ZYBIO EXI Cancer Antigen 19-9 [CA 19-9] (CLIA)

Snibe Maglumi 800 Chemiluminescence Immunoassay (CLIA) System Condition : New Real-Time Operation : Yes Portable : No Color : White & Grey Material : Other, Highgrade medical and engineering plastics, stainless steel Wall Mounted : No Operating Type : Other, Fully automated walkaway system Power Source : Other, Electric (Mains) Display Type : Other, Touchscreen LCD Noise Level : <60 dB Weight : Approximately 120 kg Power Consumption : 1000 VA Voltage : 220V AC, 50/60Hz

Snibe MAGLUMI CA 19-9 (CLIA) Condition : New Real-Time Operation : Yes Storage Instructions : Store at 2C to 8C, avoid freezing Equipment Type : Immunoassay Analyzer Reagent Kit Technology : Chemiluminescence Immunoassay (CLIA) Instruments Type : Snibe MAGLUMI Series Immunoassay Analyzer Usage Type : Clinical Laboratory / Hospital Portable : No Color : Kit/Box: White/Blue Labelled Material : Other, Diagnostic Grade Reagents (readytouse) Wall Mounted : No Operating Type : Other, Automatic (compatible with MAGLUMI platforms) Power Source : Other, External (Analyzerdependent) Display Type : Analyzerdependent Noise Level : Minimal Measurement Range : 0.5 to 1000 U/mL Function : CA 199 detection and quantification for diagnostic and monitoring purposes Features : High specificity and sensitivity, readytouse reagents, traceable calibrators, and controls Shelf Life : 12 Months (unopened) Weight : Kit Weight: Refer to packaging Use : In vitro quantitative determination of CA 199 in human serum/plasma Power Consumption : Analyzerdependent Accuracy : 10% CV (Withinrun and Betweenrun) Voltage : Analyzerdependent Dimension (L*W*H) : Kit Size: Refer to packaging

Snibe MAGLUMI PIIIP N-P (CLIA) Condition : New Real-Time Operation : Yes Storage Instructions : Store reagents at 28C Equipment Type : Immunoassay Analyzer Technology : Chemiluminescence Immunoassay (CLIA) Instruments Type : CLIAbased Analyzer Usage Type : Laboratory / Hospital Portable : No Color : White with blue accents Material : Other, Highgrade Plastic, Metal Components Wall Mounted : No Operating Type : Other, Fully Automated Power Source : Electric Display Type : Digital / Touchscreen Noise Level : Low Measurement Range : Depending on kit, e.g. 12000 pg/mL Function : Quantitative analysis of Parathyroid Hormone (PTH) Features : High specificity and sensitivity, automated operation, CLIA technology Shelf Life : As per reagent kit (typically 12 months) Use : Clinical Diagnosis of Parathyroid Hormone (PTH) Power Consumption : Approx. 300 VA Accuracy : High (as per performance studies, CV <10%) Voltage : 220 V / 50 Hz or 110 V / 60 Hz

Snibe MAGLUMI LH (CLIA) Condition : New Real-Time Operation : Yes Storage Instructions : Store at 28C Equipment Type : CLIA Immunoassay Analyzer Reagent Technology : Chemiluminescence Immunoassay (CLIA) Instruments Type : MAGLUMI Immunoassay Analyzer Usage Type : Laboratory Professional Use Portable : Yes (Kit format) Color : White (Vial Color) Material : Other Wall Mounted : No Operating Type : Automatic Power Source : Other Display Type : Not Applicable (Reagent Kit) Measurement Range : 0.1200 mIU/mL Function : LH Quantification Features : High sensitivity, specific for LH, compatible with MAGLUMI system, readytouse reagent, stable shelf life Shelf Life : 12 months Weight : Approx. per kit weight 0.25 kg Use : Quantitative determination of Luteinizing Hormone (LH) in human serum or plasma Accuracy : As per IFU (typically within laboratory requirements, e.g., CV <10%) Dimension (L*W*H) : Boxed packing, details as per manufacturer