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ThermoBrite Elite Instrument

LEICA BIOSYSTEMS MELBOURNE PTY LTD · Model 3800-007000-001 · UDI-DI 09349458005443

JRG
3
510(k) clearances
2
Adverse events
0
Recalls
24
Facilities

Description

ThermoBrite Elite automates protocols for FISH testing of pathology specimens mounted on microscope slides. ThermoBrite Elite fully automates pre and post hybridization steps while providing temperature control for on-board denaturation and hybridization. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.