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| Brand | Cytiva |
|---|---|
| Origin | Switzerland |
| Instrument Model | Sefia S-2000 |
| Type | Fully Automated |
| Regulatory Designation | Import (CE-marked for IVDR/MDR-compliant use in cell therapy manufacturing) |
| Single-Use Kit Compatibility | CT-300.1, CT-400.1 + PB-100.1, CT-200.1, CT-800.1, CT-350.1S |
| Software Integration | Chronicle™ v3.2+ with eSOP/eBMR and 21 CFR Part 11 / EU Annex 11 compliance |
| Brand | Cytiva |
|---|---|
| Origin | Switzerland |
| Type | Fully Automated |
| Model | Sefia™ Automated Cell Expansion System |
| Compliance | CE-marked (2006/42/EC), IEC 61010, IEC 61326, ICES-001 Class A, China RoHS SJ/T11364-2014 |
| Software Compliance | Chronicle™ Viewer validated per GAMP™5 and FDA 21 CFR Part 11 |
| Operating Environment | 15–25°C, 20–80% RH (non-condensing), 840–1060 mbar, indoor use only, max. altitude 2000 m |
| Consumables | Single-use FEP or silicone-based disposable kits (e.g., Cat. No. 29716713, 29739346) |
| Integration | Compatible with Chronicle™ Viewer for audit-trail-enabled data management and real-time process monitoring |
| Brand | Cytiva |
|---|---|
| Origin | Switzerland |
| Model | VIA Freeze Uno |
| Type | Fully Automatic |
| Cooling Method | Conductive |
| Compliance | cGMP, 21 CFR Part 11, ISO 13485 (via system integration) |
| Sample Capacity | 24–192 cryovials, up to 250 mL cryobags, cryostraws (with interchangeable trays) |
| Calibration | Supplied with NIST-traceable calibration certificate |
| Qualification | IQ/OQ documentation included |
| Software Integration | Chronicle™ Automation Platform (optional standalone purchase) |
| Brand | Cytiva |
|---|---|
| Origin | Switzerland |
| Model | VIA Thaw™ L1000 |
| Type | Fully Automated |
| Regulatory Classification | Import (CE-marked for IVD/medical device use in EU |
| Compliance | Designed to support GMP-compliant cell therapy manufacturing per ISO 13485, ASTM F3276-21 (Standard Guide for Cryopreserved Cellular Product Thawing), and 21 CFR Part 11–ready when used with Chronicle™ software |
| Brand | Cytiva |
|---|---|
| Origin | Switzerland |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | Sepax C-Pro Cell Processor |
| Type | Fully Automated |
| Compliance | CE (2006/42/EC), IEC 61010, IEC 61326, IEC 62304 |
| Software Integration | Chronicle eSOP, GAMP 5-aligned, FDA 21 CFR Part 11-ready audit trail capability |
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