07299001501V21.
Diluent Universal
07299001190 07299001501 36 mL
English Assay cobas e 801 cobas e 402
For use in the USA only Elecsys Vitamin D total II 07028148190 •
Intended use Elecsys Vitamin D total III 09038086190 • •
Diluent Universal is used as a sample diluent in conjunction with Elecsys
assay reagents. * Manual dilution only
Summary Reagents - working solutions
Dilution of samples is necessary when the analyte concentrations exceed Diluent Universal is labeled as Dil Uni.
the measuring range of the respective Elecsys test method. In addition,
general predilution of samples is specified for some Elecsys assays. 3 bottles containing a total usable volume of 36 mL
Contents: Protein matrix; preservative
Assay cobas e 801 cobas e 402
Precautions and warnings
Elecsys AFP 07026706190 • • For in vitro diagnostic use for health care professionals. Exercise the
normal precautions required for handling all laboratory reagents.
Elecsys AFP 09015124190 • •
Infectious or microbial waste:
Elecsys AMH 07026714190 • Warning: handle waste as potentially biohazardous material. Dispose of
Elecsys AMH 08819378190 • • waste according to accepted laboratory instructions and procedures.
Elecsys Androstenedione
Environmental hazards:
07679840190 • • Apply all relevant local disposal regulations to determine the safe disposal.
Elecsys Anti-HAV IgM 07026773190 • • Safety data sheet available for professional user on request.
Elecsys Anti-HBc IgM 07026811160 • For USA: Caution: Federal law restricts this device to sale by or on the
order of a physician.
Elecsys Anti-HBs 08343594160 •
This kit contains components classified as follows in accordance with the
Elecsys Anti-SARS-CoV-2 S 09289275190 • Regulation (EC) No. 1272/2008:
Elecsys Anti-TPO* 07026935190 • •
Elecsys CA 15-3 II 07027001190 • •
Elecsys CA 19-9 07027028190 • •
Elecsys CA 125 II 07026986190 • •
Warning
Elecsys CEA 07027079190 • •
H317 May cause an allergic skin reaction.
Elecsys CMV IgM 07027133190 • •
Prevention:
Elecsys Cortisol II 07027150190 • •
Elecsys CYFRA 21-1 07299966190 • • P261 Avoid breathing mist or vapours.
Elecsys Digoxin 07027214190 • • P272 Contaminated work clothing should not be allowed out of
Elecsys Ferritin 07027273190 • • the workplace.
Elecsys Folate 07027290190 • •
P280 Wear protective gloves.
Elecsys HBsAg II Auto Confirm 08741034190 • •
Response:
Elecsys HCG STAT 07229569190 •
P333 + P313 If skin irritation or rash occurs: Get medical
Elecsys HCG STAT 08890595190 • •
advice/attention.
Elecsys HCG+β 07251025190 • •
Elecsys hGH 07027486190 • • P362 + P364 Take off contaminated clothing and wash it before reuse.
Elecsys IgE II 07027516190 • • Disposal:
Elecsys IGF-1 07475918190 • • P501 Dispose of contents/container to an approved waste
Elecsys Myoglobin 07027583190 • • disposal plant.
Elecsys N-MID Osteocalcin 07027591190 • • Product safety labeling follows EU GHS guidance.
Contact phone: 1-800-428-2336
Elecsys proBNP II 07027664190 •
Avoid foam formation in all reagents and sample types (specimens,
Elecsys proBNP II 09315284190 • • calibrators and controls).
Elecsys Prolactin II 07027737190 • • Reagent handling
Elecsys Tacrolimus 07251254190 • • Diluent Universal is ready for use.
Elecsys total PSA 07027966190 • Place the cooled (stored at 2‑8 °C) diluent on the reagent manager. The
system automatically regulates the temperature of the reagents and the
Elecsys total PSA 08791732190 • • opening/closing of the bottles.
Elecsys Toxo IgG 07028008190 • • Storage and stability
Elecsys Toxo IgM 07028024190 • • Store at 2‑8 °C.
Elecsys Rubella IgM 07027796190 • • Stability:
Elecsys Vitamin B12 II 07028121190 • • unopened at 2‑8 °C up to the stated expiration date
2023-06, V 21.0 English 1/2
07299001501V21.0
Diluent Universal
Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
Stability: www.roche.com
on the cobas e 402 and 16 weeks +800 5505 6606
cobas e 801 analyzers
Materials provided Distribution in USA by:
Roche Diagnostics, Indianapolis, IN
▪ Diluent Universal US Customer Technical Support 1-800-428-2336
Materials required (but not provided)
cobas e 402 and cobas e 801 immunoassay analyzers and Elecsys assay
reagents
See the appropriate Elecsys assay Method Sheet and the operator’s
manual for additionally required materials.
Assay
For general predilution and for analyte concentrations above the measuring
range, see dilution recommendation in the respective Elecsys assay
Method Sheet.
Dilutions can be performed either manually by the operator or, if requested,
automatically by the analyzer via the instrument's software.
Elecsys test results
The analyte content of the diluent is in the vicinity of the lower detection
limit for the Elecsys assays and can be ignored.
For manual dilutions, the measured concentration must be multiplied by the
dilution factor to obtain the actual value in the sample. When dilution is
performed by the analyzer, this factor is automatically included in the
calculation of the sample concentration.
The concentration in the diluted sample may not be less than the stated
minimum concentration in the respective Elecsys assay Method Sheet.
For further information, please refer to the appropriate operator’s manual for
the analyzer concerned, the respective application sheets and the Method
Sheets of all necessary components (if available in your country).
Any serious incident that has occurred in relation to the device shall be
reported to the manufacturer and the competent authority of the Member
State in which the user and/or the patient is established.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard (for USA: see dialog.roche.com for
definition of symbols used):
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume for reconstitution
GTIN Global Trade Item Number
FOR US CUSTOMERS ONLY: LIMITED WARRANTY
Roche Diagnostics warrants that this product will meet the specifications
stated in the labeling when used in accordance with such labeling and will
be free from defects in material and workmanship until the expiration date
printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES.
COBAS, COBAS E and ELECSYS are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
Additions, deletions or changes are indicated by a change bar in the margin.
© 2023, Roche Diagnostics
2/2 2023-06, V 21.0 English
