FDA UDI
In Commercial Distribution
🇺🇸 United States
ThermoBrite Elite Instrument
DI: 09349458005443
·
Model: 3800-007000-001
·
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ThermoBrite Elite Instrument
- Primary DI
- 09349458005443
- Version / Model
- 3800-007000-001
- Catalog Number
- 3800-007000-001
- Company Name
- LEICA BIOSYSTEMS MELBOURNE PTY LTD
- Labeler DUNS
- 753184944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-18
- Public Version
- 2
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- b80cfa7e-7702-4957-a27e-360e0c6cfb4d
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JRG | Block, Heating | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62262 | Microscope slide hybridization/denaturation incubator IVD | An electrically-powered laboratory instrument intended to be used for the incubation of microscope slides for the denaturation and/or hybridization of a clinical specimen as part of an in situ hybridization (ISH) and/or fluorescence in situ hybridization (FISH) protocol. It is typically a bench-top unit with the capacity to hold multiple previously-prepared slides (i.e., fixed slides with/without added reagents) and is programmable to provide an optimum environment for ISH/FISH procedures (e.g., by controlling temperature, humidity and incubation time). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09349458005443 | GS1 |