Leica Biosystems Nussloch GmbH

Address:HEIDELBERGER STR. 17-19,NUSSLOCH Baden-Wurttemberg,DE

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Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

- Catalog Number : 14049559058

Device Description : The ASP6025 S Tissue Processor is a modular tissue processor for the following l The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use.

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

- Catalog Number : 14049559068

Device Description : The ASP6025 S Tissue Processor is a modular tissue processor for the following l The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use.

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

- Catalog Number : 14049559088

Device Description : The ASP6025 S Tissue Processor is a modular tissue processor for the following l The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use.

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

- Catalog Number : 14048858005

Device Description : The HistoCore PEGASUS is an automated tissue processor specifically designed for The HistoCore PEGASUS is an automated tissue processor specifically designed for fixation, dehydration, infiltration with intermedium and paraffin infiltration of human tissue specimens used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. The HistoCore PEGASUS is designed for in vitro diagnostic applications.

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1

- Catalog Number : 14048858007

Device Description : The HistoCore PEGASUS Plus is an automated tissue processor specifically designe The HistoCore PEGASUS Plus is an automated tissue processor specifically designed for fixation, dehydration, infiltration with intermedium and paraffin infiltration of human tissue specimens used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. The HistoCore PEGASUS Plus is designed for in vitro diagnostic applications.

Device Class : 1

Duns Number: 315539452

Premarket Exempt : Yes

Product Code : IEO

Prescription Use : No

Device Count : 1