FDA.reportPublic FDA data

HistoCore PELORIS

Primary DI
09349458005559
Brand
HistoCore PELORIS
Company
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Model
HistoCore I-Scan Kit
Catalog number
S45.4507
Device description
A barcode scanner, a built-in camera and an LCD screen t at displays the images captured by the camera. The scanner can be used for performing the same functions as a conventional barcode scanner and the built-in camera is used for capturing images of he baskets filled with cassettes.
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
IEOProcessor, Tissue, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IEOProcessor, Tissue, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349458005559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349458005559093494580055599349458005559

GMDN Terms#

Term, Definition table
TermDefinition
Tissue processor IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
753184944
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09349458005443ThermoBrite Elite Instrument3800-007000-0013800-007000-0012022-07-18
09349458005672BOND-III Processing ModuleBOND-IIIRS21.22012025-06-30
09349458005689BOND-MAX Processing ModuleBOND-MAXRS49.00512025-06-30
09349458005665BOND-PRIME automated stainerBOND-PRIMERS91.00212024-10-18
09349458005634BONDPrinter Ribbon & Labels for Cognitive Cxi (6 Pack)S21.46042024-08-02
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410009PathTezt®BIOCYTECH CORPORATION SDN. BHD.IEO2026-03-11
09551020410016PathTezt®BIOCYTECH CORPORATION SDN. BHD.IEO2026-03-11
04946433600584Tissue-VIP® 6 AISAKURA FINETEK U.S.A., INC.IEO2024-10-11
05051663518581EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
05051663518598EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
05051663518604EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-06-13
05051663517294EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517317EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517324EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517331EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517348EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517355EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517546EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517553EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517577EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517607EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517614EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517621EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517683EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517850EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
05051663517867EprediaSHANDON DIAGNOSTICS LIMITEDIEO2024-02-14
09349458005573HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2023-08-30
09349458005580HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2023-08-30
05051663009386EprediaSHANDON DIAGNOSTICS LIMITEDIEO2023-07-28
B92114709HistoPro®RUSHABH INSTRUMENTS, LLCIEO2022-12-18
09349458004811HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-20
09349458004712HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004729HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004736HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18
09349458004743HistoCore PELORISLEICA BIOSYSTEMS MELBOURNE PTY LTDIEO2022-07-18