LEICA BIOSYSTEMS MELBOURNE PTY LTD

Address:495 BLACKBURN RD.,MELBOURNE Victoria,AU

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Device Description : The BOND system automates clinical protocols for immunostaining of pathology spe 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.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : Yes

Device Count : 1

Device Description : The BOND system automates clinical protocols for immunostaining of pathology spe 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.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : Yes

Device Count : 1

- Catalog Number : S21.1971

Device Description : BOND Mixing Station contains six cavities that are used to mix shortlife reagent BOND Mixing Station contains six cavities that are used to mix shortlife reagents that must be mixed just before use. The mixing of the reagents is determined by thesoftware, depending on reagent type.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

- Catalog Number : S21.4610

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 : S21.4611

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 160.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

- Catalog Number : S21.4615

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 : S45.4503

Device Description : Contain cassettes with specimens and are stacked into the retorts. Includes divi Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure cassettes are correctly spaced for optimal processing.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

- Catalog Number : S45.4504

Device Description : Accepts most common cassette types and includes configurable dividers that allow Accepts most common cassette types and includes configurable dividers that allow for different cassette sizes and packing

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

- Catalog Number : S45.4505

Device Description : Contain cassettes with specimens and are stacked into the retorts. Includes divi Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure cassettes are correctly spaced for optimal processing.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

- Catalog Number : S45.4506

Device Description : Accepts most common cassette types and includes configurable dividers that allow Accepts most common cassette types and includes configurable dividers that allow for different cassette sizes and packing densities.

Device Class : 1

Duns Number: 753184944

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1