MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA)

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

Snibe MAGLUMI 25-OH Vitamin D (CLIA) Instruments Type : CLIA analyzer reagent Technology : Chemiluminescence Immunoassay (CLIA) Equipment Type : Immunoassay Analyzer Reagent Kit Condition : New Storage Instructions : 28C, avoid freezing Real-Time Operation : Yes Usage Type : Laboratory diagnostic Shelf Life : 12 months from manufacturing Power Source : Other, External used in MAGLUMI platform (powered by main unit) Features : High accuracy, wide measuring range, liquid reagents, readytouse, calibration stability Portable : No Wall Mounted : No Accuracy : CV 10% (intra and interassay precision) Color : Colorless liquid reagents, standard manufacturer packaging Use : Quantitative determination of 25OH Vitamin D in human serum or plasma Operating Type : Other, Automated Material : Other, Diagnostic reagents (liquid stable format) Function : Quantitatively measures 25OH Vitamin D (D2 & D3) Measurement Range : 4.0 120 ng/mL Display Type : Not Applicable (analyzer dependent) Power Consumption : Not Applicable; kit used in automated analyzer Dimension (L*W*H) : Box packaging varies by kit size Weight : Depends on kit size (approx. 0.5 kg/box)

Snibe MAGLUMI D-dimer (CLIA) Instruments Type : MAGLUMI Immunoassay Analyzers Technology : Chemiluminescence Immunoassay (CLIA) Equipment Type : Ddimer Reagent Kit (CLIA) Condition : New Storage Instructions : 28C, avoid freezing Real-Time Operation : Other, Yes, compatible with MAGLUMI system Usage Type : Laboratory/Clinical Shelf Life : 12 months Power Source : Other, N/A (analyzerdependent) Features : High sensitivity and specificity, rapid throughput, traceable calibrators, onboard stability Portable : No, analyzerbased Wall Mounted : No Accuracy : Meets IFCC performance criteria; CV 6% Color : White/transparent reagent vials Use : Quantitative determination of Ddimer in human plasma Operating Type : Other, Automated (requires MAGLUMI immunoassay analyzer) Material : Other, IVDgrade reagent, biological buffers, chemical reagents Function : Diagnosis/exclusion of thromboembolic events such as DVT and PE Measurement Range : 0.05 20 mg/L FEU Display Type : N/A (display via analyzer) Dimension (L*W*H) : Kit packaging as per manufacturers standard Weight : As per kit size

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