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HistoCore
SPECTRA
H&E Staining System
S1
3801654
S2
3801655
HistoCore SPECTRA H&E Staining System S1/S2
The HistoCore SPECTRA H&E Staining System S1/ S2 contain 5 proprietary reagent components and staining protocols that
when used together provide consistent diagnostic quality and ease of use. These systems have been optimized for use on
HistoCore SPECTRA ST stainers.
Intended Use
Detection/Measurement
The HistoCore SPECTRA H&E Staining System does not detect or measure an analyte or marker. HistoCore SPECTRA H&E Staining System
is used to provide coloration and contrast to tissue sections mounted on microscopic slides from paraffin embedded specimens.
The components of the stain system stain cell nuclei blue and color the connective tissue, cytoplasm, muscle and erythrocytes various
shades of orange, pink and red.
Product Function
The coloration and contrast the HistoCore SPECTRA H&E Staining Systems provides to tissue sections allows visualization to
microscopic anatomy. This visualization, when interpreted by a trained professional, is utilized alongside other information such as
the patient's medical history, physical condition, as well as results from other medical testing to render a medical diagnosis.
Specific Information Provided
HistoCore SPECTRA H&E Staining System is not intended for the detection, definition or differentiation of a specific disorder,
condition or risk factor. The staining demonstrated with use of this product, when used as intended, provides trained professionals
information which may define the physiological or pathological state of the tissue specimen.
Automation
The HistoCore SPECTRA H&E Staining System is not automated but is intended for use on the HistoCore SPECTRA ST automated stainer.
Quality/Quantity
The HistoCore SPECTRA H&E Staining System is quantitative.
Specimen Type
The HistoCore SPECTRA H&E Staining System can be used with any paraffin embedded human or animal specimen.
Testing Population
The HistoCore SPECTRA H&E Staining System is intended for use with any patient requiring histopathologic evaluation of biopsy
or resection tissue for the assessment of a suspected pathology or disease.
In Vitro Diagnostic
The HistoCore SPECTRA H&E Staining System is intended for
Intended User
The HistoCore SPECTRA H&E Staining System is intended for use by qualified laboratory personnel and/or designee of the laboratory.
Test Principle
The HistoCore SPECTRA H&E Staining System functions through the attraction of charged dyes to oppositely charged molecules
within cells and tissues.
Calibrators & Controls
The HistoCore SPECTRA H&E Staining System does not require the use of any calibrators or controls. It is recommended that control
slides containing tissue fixed and processed in a similar manner to the patient specimens should be included to ensure reagents are
performing and functioning properly prior to staining the test specimens.
Reagent Limitations
The HistoCore SPECTRA H&E Staining System contains 5 proprietary reagent components. The reagents in the HistoCore
SPECTRA H&E Staining System have been developed and optimized exclusively for use on the HistoCore SPECTRA ST Stainer.
The HistoCore SPECTRA H&E Staining System is designed to be utilized with a tap water hook up to the HistoCore SPECTRA ST
Stainer. The HistoCore SPECTRA H&E Staining System is developed and optimized for use with reagent grade alcohols and xylene.
Reagents Provided
HistoCore SPECTRA H&E Staining System S1
SPECTRA Hemalast S1 (
SPECTRA Hematoxylin S1 (
SPECTRA Differentiator S1 (
SPECTRA Bluing Agent S1 (
SPECTRA Eosin S1 (
HistoCore SPECTRA H&E Staining System S2
SPECTRA Hemalast S2 (
SPECTRA Hematoxylin S2 (
SPECTRA Differentiator S2 (
SPECTRA Bluing Agent S2 (
SPECTRA Eosin S2 (
3801580, 380mL)
3801581, 380mL)
3801582, 380mL)
3801583, 380mL)
3801584, 380mL)
3801590, 380mL)
3801591, 380mL)
3801592, 380mL)
3801593, 380mL)
3801594, 380mL)
in vitro diagnostics
use only.
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