FDA.reportPublic FDA data

BOND-MAX Processing Module

Primary DI
09349458005689
Brand
BOND-MAX Processing Module
Company
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Model
BOND-MAX
Catalog number
RS49.0051
Device description
The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.
Published
2025-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KPASlide Stainer, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09349458005689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09349458005689093494580056899349458005689

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide stainer IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. 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
Serial number
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
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
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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Primary DI, Brand, Company table
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08435804518970NeoPATH ProVITRO SAKPA2025-02-20
04065271997561MIDAS® III-Plus Automated StainerSigma-Aldrich, Inc.KPA2025-01-20
06971182571326Fully Automated IHC StainerDakewe (Shenzhen) Medical Equipment Co., Ltd.KPA2024-12-27
09349458005665BOND-PRIME automated stainerLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2024-10-18
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