VI Cell Concentration Control, Vi CELL Reagents Park & Z2 Coulter Counter Reagents and Calibration solution.

RFQ/OBP389/2025/26

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. v Iso flow II Diluent Ø Formulation compatible with Beckman Coulter impedance technology Ø Electrolyte solution compatible with Z Ø Balanced electrolyte solution with stable conductivity suitable for cell sizing/counting Ø Non-hemolytic, non-toxic, free of particulate contaminants Ø Supplied in ready-to-use format v Performance: Ø Conductivity and osmolality suitable for animal cell suspensions Ø Validated for use with Z2 Coulter Counter Ø Aperture Diameter of (100μm ) v Packaging/Volume: Ø 5 L / bottle v Performance: Ø Demonstrated complete Cell lysis in standard dilutions Ø Minimal cell debris post-lysis for reliable counts v Coulter Cleaning Solution Ø Chemically formulated for safe cleaning of apertures and fluid lines Ø Compatible with plastic/metal components of the Z2 syste Ø Non-abrasive, non-corrosive Ø Removes debris, salts, and biological residue Ø Packaging/Volume Options: v Packaging/Volum Ø 5 L / bottle v Performance: Ø Effective for routine flush and deep-clean cycles Ø Does not affect future sample integrity v Calibration Standards (Latex Beads) v Bead Types: Ø Monodisperse latex microspheres of known diameters Ø Typical sizes required: 10 µm v Concentration: Known bead count concentration (beads/mL) certified per lot High stability suspending medium (non-agglomerating) v Performance Criteria: Ø Tight size distribution (low CV % specified for each bead population) Ø Stable over defined shelf life Ø Compatible with Z2 impedance counting v Format: Ø Single bead size in via Ø Volumes: 20ml v Common Documentation Required (for All Items) Ø Certificate of Analysis (CoA) Per lot, showing tested specifications Ø Safety Data Sheets (SDS) Latest revision Ø Lot traceability and manufacturing Date Ø Storage conditions and self-liflife

Request for Quote

2026/03/20 16:00:00

No

RFQ/OBP389/2025/26