MAGLUMI HAV IgM (CLIA)

Snibe MAGLUMI Anti-TPO (CLIA) Usage Type : Clinical Laboratory Use Instruments Type : Reagent Cartridge for MAGLUMI System Real-Time Operation : Yes Technology : Chemiluminescence Immunoassay (CLIA) Condition : New Equipment Type : Immunoassay Reagent Kit Storage Instructions : Store at 28C, Protect from light Features : High Sensitivity, High Specificity, Fast Results, Readytouse Reagents Shelf Life : 12 months Wall Mounted : No Color : Clear/Transparent (Reagent Bottles) Portable : No Operating Type : Automatic Material : Other, Diagnostic Grade Biochemicals Accuracy : Excellent analytical accuracy (Analyzer dependent) Use : Detection of AntiThyroid Peroxidase Antibodies Measurement Range : Dependent on Analyzer (typically 01000 IU/mL) Function : Qualitative and Quantitative Detection of AntiTPO Dimension (L*W*H) : Analyzer accessory Power Source : Other, MAGLUMI Automated Analyzer Weight : Analyzer accessory Display Type : Not Applicable (Depends on Analyzer) Power Consumption : Depends on MAGLUMI Analyzer Voltage : Analyzerspecific

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

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

Snibe MAGLUMI CK-MB (CLIA) Usage Type : Hospital, Clinical Laboratory Instruments Type : Compatible with Snibe MAGLUMI Series Analyzers Real-Time Operation : Yes Technology : Chemiluminescence Immunoassay (CLIA) Condition : New Equipment Type : InVitro Diagnostic Reagent Kit Storage Instructions : Store at 28C Features : High sensitivity, specific detection, rapid turnaround time Shelf Life : 12 months Wall Mounted : No Color : White/Blue Portable : Yes (kit form) Operating Type : Other, Automated Material : Other, Diagnostic reagents, plastic cartridges Accuracy : CV 10% Use : Quantitative determination of CKMB in human serum or plasma Measurement Range : 0.3150 ng/mL Function : CKMB quantitative analysis Dimension (L*W*H) : Not applicable (kit format)