ThermoBrite Elite System

ThermoBrite Elite Slide Chambers (Top view)

ThermoBrite Elite Netbook

ThermoBrite Elite

3800-007000-001

Marketing Notification Number for Medical Device 13B2X10268TBE001
Brand Name Leica ThermoBrite Elite

Just load your slides and walk away. Minimal hands-on time frees up technologists for other important tasks.

The ThermoBrite Elite automates and standardizes FISH slide preparation including deparaffinization, pretreatment, denaturation/hybridization, and post hybridization wash. Application of probe, counterstain, and coverslips are the only manual steps.

The included intuitive and user-friendly software enables users to run preloaded protocols for FFPE tissue specimens or to create up to 100 user-defined protocols. The instrument, as it is an open platform, can be programmed to work with nearly any probe or protocol, allowing the selection of up to 10 input reagents and 3 separate waste paths. The ThermoBrite Elite hybridizes with controlled, accurate temperature and can process up to 12 slides per run with the ability to adapt to smaller batches. For higher throughput, transfer slides to a standard ThermoBrite instrument to denature/hybridize and continue using your ThermoBrite Elite for new runs.

For in vitro diagnostic use only.

Product Features

Efficiency

Hands-on time reduced to 3 steps from more than 30
Frees up technologists for other tasks
Automated fluidic system

Reliability

Accurate hybridization temperature control
Average hybridization efficiency higher than 98%*
Validated on FFPE tissue*

Flexibility

Flexible system: Open system with preloaded protocols and the ability to create custom protocols (possibility to use up to 100 custom-made protocols)

Convenience

Fast setup and start of protocol
User friendly software
Small bench top unit

*based on internal validation data

Product Specifications

PART NUMBER	IVD 3800-007000-001
SLIDE-BASED APPLICATIONS	FFPE tissue
INSTRUMENT FLUIDICS	Input Fluidics Output Fluidics Compatibility: 10 reagents, 3 wastes, Common ISH / FISH reagents
DIMENSIONS & WEIGHT	Width: 62.2 cm 24.5" Height: 38.1 cm 15" Depth: 39.4 cm 15.5" Weight: ~27 kg ~60 lbs
TEMPERATURE	Control Range 25° C - 95° C 77° - 203° F Operating 15 - 40° C 59 - 104° F Relative humidity: max. 80% < 31° C (87.8° F), max. 50% at 31 - 40° C (87.7 - 104° F)

USER INTERFACE AND CONTROL	PC-based GUI Continuous data logging
SAFETY & REGULATORY	ETL, CSA, CE
POWER REQUIREMENTS	100-240 VAC, 50/60 Hz, 10A

Parts/Accessories

3801-011005-001	KIT PERIODICAL MAINTENANCE, TBE
3801-010021-001	12 PACK, PERI-TUBING KIT, FLURAN
3800-010022-001	KIT PERI-TUBE, FLURAN, 2 TUBES
3801-007900-001	INLET FLOW METER SERVICE KIT
3800-007744-001	"ASSY KIT, SLIDE CARRIER" QTY 6
3801-007900-001	INLET FLOW METER SERVICE KIT
3801-007915-001	OUTLET FLOW METER SERVICE KIT