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Instruments
Cryofixator™, Cryostainer™, and Hybrid Microscope are IVDR CE-marked and FDA-registered/listed under Owner/Operator No. 10089526.
Instrument and panel regulatory status are EU-IVDR (A) certified.
No-obligation enquiry · Typical response within one business day
Current market-specific documentation should be requested before procurement or claims use.
Cryofixator™, Cryostainer™, and Hybrid Microscope are IVDR CE-marked and FDA-registered/listed under Owner/Operator No. 10089526.
Multiplex IF reagent panels are IVDR CE-marked, with April 2026 panel status noted.
The antibody catalog is Research Use Only and is not presented for diagnostic procedures.
Custom ATTO conjugation and cell-line services are Research Use Only, delivered with appropriate QC documentation.
Patent family referenced for direct-to-slide cryofixation workflows.
Patent family referenced for capillary-gap chemistry used in multiplex staining.
The deck explicitly instructs: present "IVDR CE-marked" and "FDA-registered" exactly where applicable. Do not write "FDA-approved" or "FDA-cleared" when describing FDA registration/listing.
Product availability, regulatory status, and intended use vary by market. Current product documentation should be requested from X-ZELL before publishing procurement, tender, clinical, or distributor materials.
Request the latest market-specific documentation from X-ZELL before using claims externally.
Evidence note: Clinical performance must be established in the intended patient-specimen context. Product availability, regulatory status, and intended use may vary by market. Please contact X-ZELL for current documentation.