MAGLUMI Anti-M2-3E IgG (CLIA)

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

Snibe MAGLUMI Testosterone (CLIA) Instruments Type : Clinical Chemistry Analyzer Reagent (MAGLUMI Series) Usage Type : Laboratory Use Condition : New Technology : Chemiluminescence Immunoassay (CLIA) Equipment Type : Immunoassay Analyzer Reagent Kit Real-Time Operation : Yes Storage Instructions : Store at 28C, protect from light Portable : No Wall Mounted : No Accuracy : 10% (intra and interassay CVs) Measurement Range : 0.1330.0 ng/mL Color : Colorless to light yellow (reagents) Use : Quantitative determination of Testosterone in human serum or plasma Power Source : Other, Not Applicable (Analyzer dependent) Function : Detection and quantification of Testosterone Operating Type : Other, Fully Automated (For use with MAGLUMI analyzers) Features : High specificity and sensitivity, compatible with MAGLUMI platform, calibrated and readytouse Shelf Life : 12 months from date of manufacture Material : Other, Reagent (liquid stable) for CLIA Display Type : Not Applicable (Analyzer dependent) Voltage : Not Applicable (Analyzer dependent) Weight : Not Applicable (Test Kit/Cartridge) Frequency : Not Applicable (Kit, analyzer dependent) Power Consumption : Not Applicable (Analyzer dependent) Dimension (L*W*H) : Not Applicable (Test Kit/Cartridge)

Snibe MAGLUMI FK506 (CLIA) Instruments Type : MAGLUMI Series (e.g., MAGLUMI 800, 2000 Plus, 4000) Usage Type : Clinical Laboratory, In Vitro Diagnostic Use Only Condition : New Technology : CLIA (Chemiluminescence Immunoassay) Equipment Type : Chemiluminescence Immunoassay (CLIA) Reagent Kit Real-Time Operation : Yes Storage Instructions : Store at 28C. Do not freeze. Portable : No Wall Mounted : No Accuracy : Refer to IFU / Analyzer validation data Measurement Range : 1.0040.00 ng/mL (varies by analyzer validation) Color : White/Reagent Kit Labels Use : Quantitative determination of FK506 (Tacrolimus) in human whole blood Power Source : Other, Analyzer Powered Function : FK506 (Tacrolimus) Quantification Operating Type : Other, Automatic (Analyzer Dependent) Features : High specificity and sensitivity, CLIA based, automated workflow Shelf Life : 12 Months (from manufacturing date) Material : Other, Diagnostic Grade Chemical Reagents Display Type : Analyzer Display Voltage : Analyzer Specific Weight : Kit packaging, varies Frequency : AnalyzerControlled Power Consumption : Analyzer Specific Dimension (L*W*H) : Kit packaging, varies

Snibe MAGLUMI HCG/beta-HCG (CLIA) Instruments Type : Compatible with MAGLUMI series analyzers Usage Type : Laboratory Condition : New Technology : Chemiluminescence Immunoassay (CLIA) Equipment Type : Laboratory Diagnostic Reagent Real-Time Operation : Yes Storage Instructions : Store at 28C (do not freeze) Portable : No Wall Mounted : No Accuracy : High (as per manufacturers specification, typically >95%) Measurement Range : 0.2 10000 mIU/mL Color : Kit: White & Blue (as per manufacturer) Use : Quantitative detection of human chorionic gonadotropin (HCG/HCG) in serum or plasma Power Source : Other, Not Applicable (Used in analyzer) Function : Quantification of HCG/HCG Operating Type : Other, Automated/Analyzer Based Features : High sensitivity, rapid detection, suitable for automated analyzers, minimal handson time Shelf Life : 12 months Material : Other, Diagnostic Kit (Reagent in liquid form)