MAGLUMI Syphilis (CLIA)

Snibe MAGLUMI Total PSA (CLIA) Condition : New Technology : Chemiluminescent Immunoassay (CLIA) Real-Time Operation : Yes Equipment Type : Immunoassay Analyzer (CLIA) Storage Instructions : 28C, keep away from sunlight Usage Type : Professional Instruments Type : Compatible with MAGLUMI series analyzers Dimension (L*W*H) : Instrumentdependent (refer to analyzer specification) Power Source : Electric Function : Quantitative measurement of Total PSA in human serum Portable : No Shelf Life : 12 months Wall Mounted : No Use : Clinical Laboratory PSA Testing Accuracy : CV<10% (withinrun precision) Weight : Instrumentdependent (refer to analyzer specification) Color : White Features : High throughput, Fast results, Accurate PSA quantification Operating Type : Other, Fully Automated Material : Other, Diagnostic Reagent Measurement Range : 0.2100 ng/mL (varies by kit/analyzer) Display Type : Digital Display (on compatible analyzers) Voltage : 100240V Power Consumption : Approx. 100240V AC, 50/60 Hz Frequency : Instrumentdependent Noise Level : Low

Snibe MAGLUMI Anti-HCV (CLIA) Condition : New Technology : Chemiluminescence Immunoassay (CLIA) Real-Time Operation : Yes Equipment Type : Immunoassay Analyzer Kit Storage Instructions : Store at 28C, protected from light Usage Type : Laboratory Instruments Type : In Vitro Diagnostic Instrument Kit Dimension (L*W*H) : 690 610 580 mm Power Source : Electric Function : Detection of AntiHCV Antibodies Portable : No Shelf Life : 12 months Wall Mounted : No Use : Detection of HCV antibodies in human serum or plasma Accuracy : High (99%) Weight : 85 kg Color : White/Blue Features : High specificity and sensitivity, Rapid turnaround time, Automated process, CLIA technology Operating Type : Automatic Material : Other, Diagnostic Reagents and Consumables Measurement Range : Qualitative Display Type : LCD touchscreen Voltage : AC 220V 10%, 50/60Hz Power Consumption : 800VA Frequency : Single/Batch Testing Noise Level : Low

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

Snibe MAGLUMI Intact PTH (CLIA) Condition : New Technology : CLIA (Chemiluminescence Immunoassay) Real-Time Operation : Yes Equipment Type : Chemiluminescence Immunoassay Reagent Storage Instructions : Store at 28C Usage Type : Diagnostic Use Instruments Type : For use with MAGLUMI Series Analyzers Dimension (L*W*H) : Kit size as per manufacturer Power Source : Other Function : Quantitative Determination of iPTH in Human Serum or Plasma Portable : No Shelf Life : 1 Year Wall Mounted : No Use : Laboratory Intact Parathyroid Hormone (iPTH) Determination Accuracy : CV 10% Weight : As per packaging Color : White/Blue (Packaging) Features : High Sensitivity and Specificity, ReadytoUse, Fast Turnaround Time Operating Type : Automatic Material : Other Measurement Range : 1.62,000 pg/mL