MAGLUMI IgG (Urine Analysis) (CLIA)

Snibe MAGLUMI GAD65 (CLIA) Instruments Type : Laboratory Reagent Kit Usage Type : Clinical Laboratory Use Real-Time Operation : Yes Equipment Type : Immunoassay Analyzer Reagent Condition : New Technology : Chemiluminescence Immunoassay (CLIA) Storage Instructions : Store at 28C Shelf Life : 12 months Display Type : Analyzer Dependent Dimension (L*W*H) : N/A (Reagent Kit) Function : Quantitative detection of GAD65 autoantibody Portable : No (Reagent, analyzer dependent) Use : Detection of Glutamic Acid Decarboxylase (GAD65) Autoantibodies in human serum or plasma Accuracy : 95% Power Source : Other, Analyzer powered (Electric) Operating Type : Other, Automatic (Analyzer Required) Features : High specificity, High sensitivity, Compatible with MAGLUMI automation Measurement Range : 3.02,000 U/mL Color : Transparent/White (Reagent) Material : Other, Reagent Kit, Consumables Wall Mounted : No Weight : N/A (Reagent Kit) Frequency : Throughput up to 180 tests/hour (Analyzer dependent) Power Consumption : Depends on analyzer Voltage : Analyzer dependent

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

Snibe MAGLUMI C-Peptide (CLIA) Instruments Type : For use with MAGLUMI CLIA analyzers Usage Type : Laboratory Real-Time Operation : Yes Equipment Type : Immunoassay Analyzer Reagents Condition : New Technology : Chemiluminescent Immunoassay (CLIA) Storage Instructions : Store at 28C, do not freeze Shelf Life : 12 months from production date Display Type : Not Applicable (depends on instrument) Dimension (L*W*H) : Kit packaging: as per standard (Refer to Snibe documentation) Function : CPeptide quantification for clinical diagnostics Portable : No Use : Quantitative determination of CPeptide in human serum or plasma Accuracy : <10% CV (as per kit insert) Power Source : Other, Not Applicable (used in compatible analyzer) Operating Type : Other, Automatic (for use with MAGLUMI systems) Features : High sensitivity, specific for CPeptide, fully automated procedure, intended for clinical laboratory use Measurement Range : 0.05 30 ng/mL (as per product documentation) Color : Kit box: standard packaging (White/Blue) Material : Other, Diagnostic reagent kit for in vitro use Wall Mounted : No Weight : Kit packaging: as per standard (Refer to Snibe documentation)

Snibe MAGLUMI Rev T3 (CLIA) Instruments Type : MAGLUMI Immunoassay Analyzer Usage Type : Invitro Diagnostic Use Real-Time Operation : Yes Equipment Type : Immunoassay Analyzer Reagents Condition : New Technology : Chemiluminescence Immunoassay (CLIA) Storage Instructions : Store at 28C, do not freeze Shelf Life : 12 months from manufacture date Display Type : Not applicable (reagent kit) Dimension (L*W*H) : Not applicable (applies to reagent kit packaging) Function : Detection and quantification of Rev T3 Portable : No Use : Quantitative determination of Reverse Triiodothyronine (Rev T3) in human serum or plasma Accuracy : Consistent with reference standards; value provided with lot Power Source : Other, Not applicable (applies to instrument) Operating Type : Other, Automated Features : High sensitivity, high specificity, automated processing Measurement Range : 0.048.0 ng/mL Color : Colorless (Liquid), labeled vials Material : Other, Reagent kit, plastic vials Wall Mounted : No