LEICA BIOSYSTEMS MELBOURNE PTY LTD

Address:495 BLACKBURN RD.,MELBOURNE Victoria,AU

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- Catalog Number : 49.0005

Device Description : The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue samples for sectioning. This is achieved by transforming fixed specimens into wax infiltrated specimens by exposing them to a sequence of reagents in the tissue processor. Tissue samples subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

Device Description : The BOND system is designed for immunostaining histological specimens mounted on The BOND system is designed for immunostaining histological specimens mounted on microscope slides.

Device Class :

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : Yes

Device Count : 1

- Catalog Number : S21.4621

Device Description : The BOND Controller provides the computer that contains the software (version 6. The BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that controls the processing Module(s).

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

- Catalog Number : S21.2001

Device Description : Transparent plastic covers that sit over slides during staining, provided in a p Transparent plastic covers that sit over slides during staining, provided in a pack of 100.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

- Catalog Number : S21.4564

Device Description : Used with the slide labeller to print stick on labels to attach to slides. The s Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

- Catalog Number : S21.4604

Device Description : Used with the slide labeller to print stick on labels to attach to slides. The s Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

- Catalog Number : S21.4605

Device Description : Used to print stick-on labels to attach to slides. The labelled slides are used Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND instrument.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

- Catalog Number : 91.1592

Device Description : The BOND-PRIME ARC Refresh Kit is a consumable kit for the BOND-PRIME staining p The BOND-PRIME ARC Refresh Kit is a consumable kit for the BOND-PRIME staining platform. The kit contains two items that must be periodically replaced to maintain staining quality: a set of BOND-PRIME Covertiles and a BOND-PRIME Mixing Well Plate.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : Yes

Device Count : 1

- Catalog Number : 3800-007000-001

Device Description : ThermoBrite Elite automates protocols for FISH testing of pathology specimens mo 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 Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : JRG

Prescription Use : No

Device Count : 1

- Catalog Number : 21.2793

Device Description : The BOND System Control Kit provides the computer which contains the software (v The BOND System Control Kit provides the computer which contains the software (version 6.0/W10 IoT) that controls the Processing Modules(s), as well asthe Slide Labeler, Handheld barcode scanner, ethernet switch and power cable.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1