MAGLUMI H.Pylori IgM CLIA

Snibe MAGLUMI PRL (CLIA) Usage Type : Singleuse (kit based) Storage Instructions : Store at 28C, avoid direct sunlight Equipment Type : CLIA Immunoassay Analyzer Kit Condition : New Instruments Type : Reagent kit for MAGLUMI CLIA analyzer Real-Time Operation : Yes Technology : Chemiluminescence Immunoassay (CLIA) Weight : Standard packaging weight Color : White Measurement Range : 0.5 200 ng/mL Wall Mounted : No Operating Type : Automatic Accuracy : High, within 8% CV Shelf Life : Up to 12 months Material : Other, Medical grade consumables and reagents Dimension (L*W*H) : Standard kit size, varies per system Features : High sensitivity, rapid detection, automated sample processing, reliable results Function : Quantitative analysis of prolactin (PRL) in human serum Use : Clinical Laboratory, Diagnostics Portable : No Display Type : Not applicable (Analyzer dependent) Power Source : Electric Power Consumption : <150 VA Voltage : 100240 V

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

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

Snibe MAGLUMI Calcitonin (CLIA) Usage Type : Laboratory Use Only Storage Instructions : 28C (Refrigerated) Equipment Type : InVitro Diagnostic Reagent Kit Condition : New Instruments Type : Automated Assay System (for use with Snibe MAGLUMI analyzers) Real-Time Operation : Yes Technology : Chemiluminescent Immunoassay (CLIA) Weight : Variable, as per kit size Color : White/Transparent (Cartridge) Measurement Range : 22,000 pg/mL Wall Mounted : No Operating Type : Other, Automated Accuracy : High accuracy with low CV% (Coefficient of Variation) Shelf Life : 12 months Material : Other, Diagnostic reagents (readytouse liquid reagents in cartridges), plastic cartridge Dimension (L*W*H) : Not Applicable (for reagent kit) Features : Fast, sensitive, accurate, automated, minimal sample volume required Function : Immunoassay for calcitonin measurement Use : Quantitative determination of Calcitonin (human) in human serum or plasma