ULTRA Cell Conditioning Solution (ULTRA CC1) 7. Avoid microbial contamination of reagents, as this could produce incorrect results.

8. This reagent may cause skin and eye irritation. It may also be irritating to mucous
950-224 membranes and upper respiratory tract. An allergic respiratory or skin reaction may
be possible in sensitized individuals.
05424569001 9. ULTRA CC1 is not flammable.
10. When used according to instructions, this product is not classified as a hazardous
substance. The preservative in the reagent is ProClin 950, containing the active
ingredients 5-chloro-2-methyl-4-isothiazine-3-one and 2-methyl-4-isothiazolin-3-one.
INTENDED USE Symptoms of overexposure to ProClin 950 include skin and eye irritation, and
irritation of mucous membranes and upper respiratory tract. The concentration of
ULTRA Cell Conditioning Solution (ULTRA CC1) from Ventana Medical Systems, Inc. ProClin 950 in this product is 0.05% and does not meet the OSHA criteria for a
(Ventana) is a pre diluted solution used as a pretreatment step in the processing of tissue hazardous substance. Systemic allergic reactions are possible in sensitive
samples for immunohistochemistry (IHC) reactions carried out on the VENTANA individuals.
BenchMark ULTRA instrument.
11. Consult local or state authorities with regard to recommended method of disposal.
This product is intended for in vitro diagnostic (IVD) use. 12. For supplementary safety information, refer to the product Safety Data Sheet and
PRINCIPLE OF THE PROCEDURE the Symbol and Risk Phrase Guide located at www.ventana.com.
ULTRA CC1 is a tris based buffer which must not be diluted. ULTRA CC1 is poured into INSTRUCTIONS FOR USE
the appropriate position (ULTRA CC1 bottle) of the automated fluidics module on the Refer to the appropriate probe or detection kit package insert for the recommended
automated slide stainer. The instrument applies ULTRA CC1 automatically as required by staining protocol and to the instrument Operator’s Manual for detailed instructions and
the procedure being run on the automated slide staining system. additional protocol options.
Fixation of tissue by formalin results in the formation of covalent bonds between the ULTRA CC1 is poured into the appropriate bulk fluid bottle (ULTRA CC1 bottle) of the
aldehyde and amino groups present in the tissue. The formation of these bonds denatures automated fluidics module on the VENTANA BenchMark ULTRA instrument. ULTRA CC1
protein and can result in the loss of antigenicity. In addition, the formaldehyde can form is applied automatically as required by the protocol being run. The instrument applies
methylene bridges cross linking tissue proteins thus reducing the penetration of the tissue ULTRA CC1 automatically. Refer to the instrument Operator’s Manual for detailed
to large molecules such as antibodies. instructions and additional protocol options.
ULTRA CC1 is a tris based buffer with a slightly basic pH, which, at elevated temperatures
is capable of hydrolyzing the covalent bonds formed by formalin in tissue. Removing these PERFORMANCE CHARACTERISTICS
bonds allows renaturation of protein molecules and increases antibody accessibility. Often ULTRA CC1 is applied to tissue specimens following the removal of paraffin for paraffin-
these changes result in significant gains in antibody binding and improved signal to noise embedded sections and prior to the application of reagents used in the detection of the
ratios. The automated slide stainer automatically heats the slide to the appropriate target antigen, in conjunction with the VENTANA BenchMark ULTRA instrument.
temperature and time as selected by the user. Expected results are quantitative only when testing the sensitivity and specificity of each
specific antigen or target nucleic acid sequence. As a standalone reagent, this product
MATERIALS AND METHODS
cannot be tested for specificity or sensitivity.
Reagent Provided
TROUBLESHOOTING
One 2 L bottle of ULTRA CC1 contains a Tris-based buffer and a preservative.
For corrective action, refer to the automated slide stainer Operator’s Manual or contact
Reconstitution, Mixing, Dilution, Titration
your local support representative.
No reconstitution, mixing, dilution, or titration is required. Further dilution may result in loss
of staining specificity. The user must validate any such changes. INTELLECTUAL PROPERTY
Materials Required But Not Provided BENCHMARK, NEXES, VENTANA, and the VENTANA logo are trademarks of Roche.
Additional reagents including but not limited to VENTANA primary antibodies, probes, All other trademarks are the property of their respective owners.
detection kits, and ancillary components, are not provided. © 2011-2014 Ventana Medical Systems, Inc.
Not all products listed in the package insert may be available in all geographies. Consult CONTACT INFORMATION
your local support representative.
Storage and Handling
Store at room temperature (15-30°C). Keep out of direct sunlight. Do not freeze or Ventana Medical Systems, Inc.
refrigerate as precipitate may form at storage temperatures below those recommended. If 1910 E. Innovation Park Drive
precipitate is noted due to cold temperatures, allow the bottle to return to room Tucson, Arizona 85755
temperature and shake to dissolve precipitate. USA
+1 520 887 2155
This reagent is expiration dated. When properly stored, the reagent is stable to the date +1 800 227 2155 (USA)
indicated on the label. Do not use reagent beyond the expiration date.
www.ventana.com
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic (IVD) use.
2. For professional use only. Roche Diagnostics GmbH
3. Take reasonable precautions when handling reagents. Avoid contact of reagents Sandhofer Strasse 116
with eyes, skin, and mucous membranes. Use protective clothing and gloves. D-68305 Mannheim
4. Avoid contact of reagents with eyes and mucous membranes. If reagents come in Germany
contact with sensitive areas, wash with copious amounts of water.
5. Do not smoke, eat or drink in areas where specimens or reagents are being
handled.
6. Patient specimens and all materials contacting them should be handled as
biohazardous materials and disposed of with proper precautions. Never pipette by
mouth.

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