Address:HEIDELBERGER STR. 17-19,NUSSLOCH Baden-Wurttemberg,DE
Device Description : The ASP6025 Tissue Processor is a modular tissue processor for the following lab The ASP6025 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 can be used as medical IVD product. The improved features of the ASP6025 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
Prescription Use : No
Device Description : The ASP6025 Tissue Processor is a modular tissue processor for the following lab The ASP6025 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 can be used as medical IVD product. The improved features of the ASP6025 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
Prescription Use : No
Device Description : The HistoCore SPECTRA ST is an in-vitro diagnostics instrument. The HistoCore SP The HistoCore SPECTRA ST is an in-vitro diagnostics instrument. The HistoCore SPECTRA ST is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
Device Class : 1
Duns Number: 315539452
Premarket Exempt : Yes
Prescription Use : No
Device Description : HistoCore SPECTRA Accessory
Device Class : 1
Duns Number: 315539452
Premarket Exempt : Yes
Prescription Use : No
Device Description : The HistoCore PEARL is designed to enable tissue processing, performing all step The HistoCore PEARL is designed to enable tissue processing, performing all steps from fixation to wax infiltration. It is normally processed in sequential mode, which means that the instrument is strictly using one bottle after the other. The HistoCore PEARL is a tissue processor for the following laboratory applications: Fixation Dehydration Infiltration with intermedium Paraffin infiltration of histological tissue specimens. The HistoCore PEARL must be operated exclusively with the reagents listed in the section of Compatible reagents
Device Class : 1
Duns Number: 315539452
Premarket Exempt : Yes
Prescription Use : No
Device Description : HistoCore PEARL Accessory
Device Class : 1
Duns Number: 315539452
Premarket Exempt : Yes
Prescription Use : No
Device Class : 1
Duns Number: 315539452
Premarket Exempt : Yes
Prescription Use : No
Device Description : The Leica Small Linear Stainer ST4020 is used for the automated preparation of r The Leica Small Linear Stainer ST4020 is used for the automated preparation of routine histo¬logical and cytological stains. It is i ntended for use in pathology laboratories to assist with the following tasks: • Staining thin tissue sections or cytological specimens on slides. Frozen sections can also be stained. • The instrument may be operated only ccording to the instructions contained in this manual.
Device Class : 1
Duns Number: 315539452
Premarket Exempt : Yes
Prescription Use : No
Device Description : The HistoCore SPECTRA CV is a fully automated coverslipper that is used to apply The HistoCore SPECTRA CV is a fully automated coverslipper that is used to apply mounting media between the slide and coverglass. Then a coverglass is applied in order to preserve conserve the specimen and to create a uniform visual surface for microscopic research on histological and cytological tissue samples for medical diagnostics (e.g. cancer diagnostics). This instrument may be operated only in conjunction with the coverglasses and mounting media approved by Leica.
Device Class : 1
Duns Number: 315539452
Premarket Exempt : Yes
Prescription Use : No
Device Description : HistoCore SPECTRA Accessory
Device Class : 1
Duns Number: 315539452
Premarket Exempt : Yes
Prescription Use : No