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ThermoBrite Elite Instrument

Primary DI
09349458005443
Brand
ThermoBrite Elite Instrument
Company
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Model
3800-007000-001
Catalog number
3800-007000-001
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.
Published
2022-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JRGBlock, Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRGBlock, HeatingClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349458005443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349458005443093494580054439349458005443

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide hybridization/denaturation incubator IVDA mains electricity (AC-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 hybridisation (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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
753184944
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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09349458005641BONDPrinter Ribbon & Labels for Cognitive Cxi (6 Pack)S21.46102024-08-02
09349458005658BONDCognitive LabellerS21.46052024-08-02
09349458005627BONDZebra ZD421 Label Printer SpareS21.46322024-04-05
09349458005573HistoCore PELORISHistoCore PELORIS 3 Win10/I-Scan Upgrade KitB45.51202023-08-30
09349458005580HistoCore PELORISHistoCore PELORIS 3 Win10 Upgrade KitB45.51212023-08-30
09349458004811HistoCore PELORISHistoCore PELORIS 3 (100-120V)49.00052022-07-20
09349458004712HistoCore PELORISSpaced Basket KitS45.45032022-07-18
09349458004729HistoCore PELORISHigh Capacity Basket KitS45.45042022-07-18
09349458004736HistoCore PELORISBasket SpacedS45.45052022-07-18
09349458004743HistoCore PELORISHigh Capacity Basket (with dividers)S45.45062022-07-18
09349458005559HistoCore PELORIS HistoCore I-Scan KitS45.45072022-07-18
09349458005566HistoCore PELORIS HistoCore PELORIS 3 Barcode Scanner KitS45.45082022-07-18
09349458002657BONDZebra GX430t Label Printer SpareS21.46152022-07-20
09349458000004BOND-III processing moduleBOND-III21.22012022-07-18
09349458000011BOND-MAX Processing ModuleBOND-MAX49.00512022-07-18
09349458001261BONDBOND Mixing Stations (5 pack)S21.19712022-07-18

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