ThermoBrite Elite Instrument
ThermoBrite Elite automates protocols for FISH testing of pathology specimens mounted on microscope slides. ThermoBrite Elite fully automates pre and post hybridization steps while…
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.
Who Else Makes It
Concentrated in Zhejiang (3), Shandong (2), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Hunan Xiang YI Laboratory Instrument Development Co., Ltd. | Changsha | Hunan | Manufacturer | 7 |
| Hangzhou Bioer Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| LAB Fish Equipment (Zhejiang) Co., Ltd., | Huzhou | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Leica Biosystems Melbourne PTY Ltd, Australia |
|---|---|
| FDA product code | JRG |
| Device type | Block, Heating |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2050 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-18 |
| Record revised | 2026-02-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3800-007000-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ThermoQ | Hangzhou Bioer Technology Co., Ltd. | 20 |
| AmpliVue | Diagnostic Hybrids, Inc. | 6 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 4 |
| Verify | Steris Corporation | 4 |
| ThermoBrite | Leica Biosystems Richmond, Inc. | 4 |
| Thermo Cell | Hangzhou Bioer Technology Co., Ltd. | 2 |
| Thermo Shaker Mixing Block | Hangzhou Bioer Technology Co., Ltd. | 1 |
| Thermo Cell Mixing Block | Hangzhou Bioer Technology Co., Ltd. | 1 |
| Block, Heating | Steris Corporation | 1 |
| Fibrinotherm | Baxter Healthcare Corporation | 1 |
| HemoTemp II Activator | Biosynergy, Inc. | 1 |
| HemoTemp II Activator | LCR Hallcrest, LLC. | 1 |
Showing 12 of 13. All products under Block, Heating
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.