RFQ/OBP099/2026/27

VI Cell Concentration Control, Vi CELL Reagents Park & Z2 Coulter Counter Reagents and Calibration solution.
RFQ/OBP099/2026/27
2 VI Cell Concentration Control Supply of concentration control material for verification of cell concentration measurements on the Vi-CELL automated cell viability analyser. 1.Product Description A stabilized latex bead suspension with certified nominal concentration used to verify instrument concentration accuracy and performance. 1.1 Compatibility o Must be fully compatible with: o Vi-CELL XR analyzer 1.2 Nominal bead Concentration For Vi-CELL XR: o 1 × 10⁶ beads/mL 1.3 Physical Characteristics • Format: Latex bead suspension control standard. • Sterility: Non-biological control material • Homogeneous suspension • Suitable for automated aspiration systems 1.4 Packaging • 20 mL bottle. 1.5 Storage & Stability • typically 2–8°C • Minimum remaining shelf life upon delivery: ≥ 70% of total shelf life or ≥ 12months (whichever is longer) Quality Documentation Supplier shall provide: • Certificate of Analysis (CoA) • Certificate of Conformance (CoC) • Safety Data Sheets (SDS) • Instructions for Use (IFU) • Manufacturer ISO certification details (ISO 9001 / ISO 13485, if applicable) 2 2 Vi CELL Reagents Park This specification defines the requirements for the supply of Vi-CELL Reagent Pack for use with automated cell viability analyzers. Equipment Compatibility The reagent pack be fully compatible with: • Vi-CELL XR Kit Components • Trypan Blue solution 0.4% (w/v) • Cleaning solution • Buffer Solution • Rinse solution / system fluid (Disinfectant) Performance • Support accurate cell concentration and viability measurements. • Compatible with automated aspiration and mixing systems. • Formulations stable and free from precipitation or particulate contamination. • Lot-to-lot consistency maintained. Storage & Shelf Life • Minimum shelf life upon delivery: at least 12 months or ≥70% of total shelf life. Quality Documentation Supplier shall provide: • Certificate of Analysis (CoA) • Certificate of Conformance (CoC) • Safety Data Sheets (SDS) • Instructions for Use (IFU) • Manufacturer ISO certification details (ISO 9001 / ISO 13485, if applicable) (1X5L)eac Z2 Coulter Counter Reagents and Calibration solution This specifications defines Reagent packs for the Beckman Coulter Z2 Coulter Counter essential consumables.  Iso flow II Diluent  Formulation compatible with Beckman Coulter impedance technology  Electrolyte solution compatible with Z  Balanced electrolyte solution with stable conductivity suitable for cell sizing/counting  Non-hemolytic, non-toxic, free of particulate contaminants  Supplied in ready-to-use format  Performance:  Conductivity and osmolality suitable for animal cell suspensions  Validated for use with Z2 Coulter Counter  Aperture Diameter of (100μm )  Packaging/Volume:  5 L / bottle  Performance:  Demonstrated complete Cell lysis in standard dilutions  Minimal cell debris post-lysis for reliable counts  Coulter Cleaning Solution  Chemically formulated for safe cleaning of apertures and fluid lines  Compatible with plastic/metal components of the Z2 syste  Non-abrasive, non-corrosive  Removes debris, salts, and biological residue  Packaging/Volume Options:  Packaging/Volum  5 L / bottle  Performance:  Effective for routine flush and deep-clean cycles  Does not affect future sample integrity  Calibration Standards (Latex Beads)  Bead Types:  Monodisperse latex microspheres of known diameters  Typical sizes required: 10 µm  Concentration: Known bead count concentration (beads/mL) certified per lot High stability suspending medium (non-agglomerating)  Performance Criteria:  Tight size distribution (low CV % specified for each bead population)  Stable over defined shelf life  Compatible with Z2 impedance counting  Format:  Single bead size in via  Volumes: 20ml  Common Documentation Required (for All Items)  Certificate of Analysis (CoA) Per lot, showing tested specifications  Safety Data Sheets (SDS) Latest revision  Lot traceability and manufacturing Date  Storage conditions and self-liflife
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2026/07/13 16:00:00
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