MAGLUMI IA 2 (CLIA)

Snibe MAGLUMI AFP (CLIA) Storage Instructions : Store at 28C, protect from light Usage Type : Hospital, Pathology Lab, Diagnostic Center Measurement Range : 0.5 1000 ng/mL (Typical, refer to product insert) Technology : Chemiluminescence Immunoassay (CLIA) Power Source : Other, External (For MAGLUMI Analyzer Equipment) Wall Mounted : No Use : Quantitative determination of Alphafetoprotein (AFP) in human serum or plasma Accuracy : Within manufacturerspecified range (Refer to IFU/Insert for detailed statistics) Material : Other, Readytouse liquid reagents in sealed vials Dimension (L*W*H) : Not Applicable (Reagent Kit) Function : Alphafetoprotein (AFP) marker detection & quantitation Portable : No Shelf Life : 12 months from date of manufacture Equipment Type : Immunoassay Analyzer Reagent Instruments Type : Immunoassay Analyzer Kit Real-Time Operation : Yes Color : White/Transparent (Reagent Solution) Features : High sensitivity and specificity, automation compatible, readytouse reagents, wide measuring range Condition : New Operating Type : Other, Automated Display Type : Not Applicable (Kit) Frequency : Not Applicable (Kit) Voltage : Not Applicable (Reagent Kit) Power Consumption : Not Applicable (Reagent Kit) Weight : Not Applicable (Reagent Kit)

Snibe MAGLUMI FT3 (CLIA) Storage Instructions : Store at 28C. Do not freeze Usage Type : Laboratory Measurement Range : Reference range: 2.36.3 pmol/L (varies; analyzerdependent) Technology : CLIA (Chemiluminescent Immunoassay) Power Source : Other, Dependent on MAGLUMI Analyzer (External Electric) Wall Mounted : No Use : Quantitative determination of Free Triiodothyronine (FT3) in human serum or plasma Accuracy : High accuracy; CV 10% Material : Other, Diagnostic Chemicals, Biological reagents Dimension (L*W*H) : Kit box dimensions vary; refer to packaging Function : Immunoassaybased FT3 quantification Portable : Yes (kit form) Shelf Life : 12 months from date of manufacture Equipment Type : FT3 Chemiluminescent Immunoassay (CLIA) Reagent Kit Instruments Type : Compatible with Snibe Maglumi CLIA analyzers Real-Time Operation : Other, Yes (Automated analyzer compatible) Color : White/colored reagent vials per kit packing Features : High specificity, precise quantitative results, suitable for fully automated Maglumi System, short turnaround time Condition : New Operating Type : Other, Automated Display Type : Not applicable; readout via Maglumi analyzer Frequency : As per analyzer setting Voltage : As per MAGLUMI Analyzer specifications Power Consumption : As per MAGLUMI Analyzer specifications Weight : Approximate kit boxed weight 0.51 kg

Snibe MAGLUMI free beta-HCG (CLIA) Storage Instructions : Store at 28C, protect from light Usage Type : Laboratory diagnostic Measurement Range : 0.1200 ng/mL Technology : Chemiluminescent Immunoassay (CLIA) Power Source : Other, Analyzerdependent (external power supply) Wall Mounted : No Use : Quantitative determination of free betaHCG in human serum or plasma Accuracy : CV 10% Material : Other, Diagnostic biochemistry reagents, buffer solutions Dimension (L*W*H) : Box size approx. 14 x 12 x 8 cm Function : Detection and quantitation of free beta subunit of HCG Portable : No Shelf Life : 12 months from manufacturing date Equipment Type : CLIA Analyzer Reagent Kit Instruments Type : For use with MAGLUMI series automatic analyzer Real-Time Operation : Yes Color : White reagent kit with clear labeling Features : High sensitivity, rapid results, stable reagents, readytouse Condition : Other, New, Sealed packaging Operating Type : Other, Automatic with compatible analyzer Display Type : Results displayed via compatible analyzer Frequency : Analyzercontrolled, per run requirements Voltage : Analyzerdependent Power Consumption : Analyzerdependent Weight : Approx. 0.5 kg per kit

Snibe MAGLUMI free Estriol (CLIA) Storage Instructions : Store at 28C Usage Type : Clinical Laboratory Diagnostic Measurement Range : 0.4200 ng/mL Technology : Chemiluminescence Immunoassay (CLIA) Power Source : Other, Not Applicable (used with MAGLUMI system) Wall Mounted : No Use : Quantitative determination of free Estriol (uE3) in human serum or plasma Accuracy : High (dependent on instrument) Material : Other, Diagnostic Reagent Kit Dimension (L*W*H) : Not Applicable (reagent kit) Function : Measures unconjugated estriol concentration for prenatal screening Portable : No (used on dedicated analyzer) Shelf Life : 12 months Equipment Type : Immunoassay Analyzer Reagent Instruments Type : MAGLUMI Immunoassay Analyzer Real-Time Operation : Yes Color : White (Kit Packaging) Features : High sensitivity, High specificity, Automated process, Readytouse reagents Condition : New Operating Type : Other, Automated Display Type : Not Applicable (used with analyzer)