11887459001V8.

Precimat Chromogen
11012045 122 6 x 0.5mL Calibrator

English P501 Dispose of contents/container to an approved waste

System information disposal plant.
For use on Roche/HitachiMODULAR and cobasc analyzers the calibrator Contact phone: all countries: +49-621-7590
code is 430.
Handling
For use on COBASINTEGRA analyzers the systemID is 0765856. Carefully open one bottle, avoiding the loss of lyophilizate, and pipette in
For use on CoasysPlusC analyzers. exactly 0.5mL of distilled/deionized water.
Intended use Carefully close the bottle and dissolve the contents completely by
PrecimatChromogen is for use in the calibration of quantitative Roche occasional gentle swirling within 30minutes. Do not shake. Avoid the
methods on Roche clinical chemistry analyzers as specified in the enclosed formation of foam. Leave the solution to stand for at least 30minutes before
value sheet. use.
The enclosed barcoded labels are intended exclusively for
Summary Roche/HitachiMODULAR automated analyzers and cobasc systems to
PrecimatChromogen is a lyophilized calibrator based on human citrated identify the calibrator. Attach the barcoded labels to the tubes carrying the
plasma. The concentrations of the calibrator components have been sample cups containing the calibrator material.
adjusted to ensure optimal calibration of the appropriate Roche methods on
clinical chemistry analyzers. Storage and stability
Some methods specified in the relevant value sheet may not be available in Store at 28C.
all countries. Criterion for the stability data stated by Roche:
Reagents - working solutions Recovery within 10% of initial value.
Reactive components in the lyophilizate: Stability of the lyophilized calibrator at 28C: Up to the stated expiration
Antithrombin III date.
Non-reactive components: Stability of the components in the reconstituted calibrator:
Preservatives and stabilizers. at 1525C: 8hours
The concentrations of the components are lot-specific. The exact calibrator at 28C: 5days
values are given in the electronically available or enclosed value sheets
The values are also encoded in the enclosed calibrator barcode sheets for at (-15)(-25)C: 4weeks (when frozen once)
Roche/HitachiMODULAR, COBASINTEGRA and CoasysPlusC Store calibrator tightly capped when not in use.
analyzers.
Materials provided
For the cobasc analyzers (except for the cobasc111 analyzer) the values
are encoded in electronic files sent via the cobas link to the analyzers. See Reagents working solutions section
Calibrator values Barcoded labels
The calibrator values were determined using the method stated in the Materials required (but not provided)
electronically available or enclosed value sheets. Determinations were Roche system reagents and clinical chemistry analyzers
performed under strictly standardized conditions on Roche analyzers using
Roche system reagents and the Roche master calibrator. General laboratory equipment
The calibrator values were obtained via single determinations performed in Assay
different laboratories, in several separate runs. The calibrator value Use PrecimatChromogen as specified in the relevant Method Sheet for the
specified is the median of all values obtained. system reagents.
Traceability information is given in the relevant Method Sheets for the References
system reagents.
1 Occupational Safety and Health Standards: Bloodborne pathogens.
Precautions and warnings (29CFR Part 1910.1030). Fed. Register.
For in vitro diagnostic use. 2 Directive 2000/54/EC of the European Parliament and Council of
Exercise the normal precautions required for handling all laboratory 18September 2000 on the protection of workers from risks related to
reagents. exposure to biological agents at work.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request. A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
All human material should be considered potentially infectious. All products a decimal numeral. Separators for thousands are not used.
derived from human blood are prepared exclusively from the blood of
donors tested individually and shown to be free from HBsAg and antibodies Symbols
to HCV and HIV. Roche Diagnostics uses the following symbols and signs in addition to
The testing methods applied were FDA-approved or cleared in compliance those listed in the ISO 152231 standard.
with the European Directive 98/79/EC, AnnexII, ListA.
However, as no testing method can rule out the potential risk of infection Contents of kit
with absolute certainty, the material should be handled with the same level
of care as a patient specimen. In the event of exposure, the directives of the Calibrator
responsible health authorities should be followed.1,2 Volume after reconstitution or mixing

This kit contains components classified as follows in accordance with the PRECIMAT, MODULAR, COBAS, COBASC, COASYS and COBASINTEGRA are trademarks of Roche.
Regulation (EC) No. 1272/2008: All other product names and trademarks are the property of their respective owners.
Significant additions or changes are indicated by a change bar in the margin.
H412 Harmful to aquatic life with long lasting effects. 2013, Roche Diagnostics

Prevention:
P273 Avoid release to the environment.
Disposal:

2016-06, V 8.0 English 1/2

11887459001V8.0

Precimat Chromogen
Roche Diagnostics GmbH, SandhoferStrasse116, D-68305 Mannheim
www.roche.com

2/2 2016-06, V 8.0 English