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ThermoBrite Elite Instrument

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Melbourne Pty Ltd

Identity

Trade Name
ThermoBrite Elite Instrument FDA UDI
Generic Name
Microscope slide hybridization/denaturation incubator IVD FDA UDI
Device Name
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. FDA UDI
Model / Reference
3800-007000-001 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
3800-007000-001 FDA UDI
Primary DI / UDI-DI
09349458005443 FDA UDI
FDA Product Code
JRG FDA UDI
GMDN Term
Microscope slide hybridization/denaturation incubator IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microscope slide hybridization/denaturation incubator IVD

ThermoBrite Elite Instrument by Leica Biosystems Melbourne Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microscope slide hybridization/denaturation incubator IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Leica Biosystems Melbourne Pty Ltd

Sources (1)

  • FDA UDI b80cfa7e-7702-4957-a27e-360e0c6cfb4d 34 fields · synced Jun 8, 2026