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    Prolactin Ii Calset: Please Note: Both The Vial Labels, and The Additional Labels (If Available)

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    Prolactin Ii Calset: Please Note: Both The Vial Labels, and The Additional Labels (If Available)

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    Prolactin Ii Calset: Please Note: Both The Vial Labels, and The Additional Labels (If Available)

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    Jimboreanu György Paula
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    ms_03277356190V7.

    Prolactin II CalSet
     03277356 190 4 x 1.0 mL
    For USA: cobas Elecsys Prolactin II CalSet

    English Materials provided


    Intended use ▪ Prolactin II CalSet, barcode card, calibrator barcode sheet, 4 empty
    Prolactin II CalSet is used for calibrating the quantitative Elecsys Prolactin II labeled snap‑cap bottles, 2 x 6 bottle labels
    assay on the Elecsys and cobas e immunoassay analyzers. Materials required (but not provided)
    Summary ▪  11776576322, CalSet Vials, 2 x 56 empty snap‑cap bottles
    Prolactin II CalSet is a lyophilized buffered equine serum matrix with added ▪ MODULAR ANALYTICS E170 or cobas e immunosassay analyzers and
    recombinant prolactin in two concentration ranges. Elecsys Prolactin II assay reagents.
    The CalSet can be used with all reagent lots. ▪ Distilled or deionized water
    Reagents - working solutions See the assay Method Sheet and the operator’s manual for additionally
    ▪ PRL Cal1: 2 bottles, each for 1.0 mL of calibrator 1 required materials.
    ▪ PRL Cal2: 2 bottles, each for 1.0 mL of calibrator 2 Assay
    Prolactin (human, recombinant, from E. coli) in two concentration ranges Place the reconstituted calibrators (in the system-compatible bottles with
    (approximately 2 µIU/mL or 0.09 ng/mL and approximately 2000 µIU/mL or barcoded labels) in the sample zone.
    94 ng/mL) in a buffered equine serum matrix. Read in all the information necessary for calibrating the assay.
    cobas e 801 analyzer: The exact lot‑specific calibrator values are encoded Ensure the calibrators are at 20‑25 °C prior to measurement.
    in the electronic barcode and available via the cobas link. For further information, please refer to the appropriate operator’s manual for
    All other analyzers: The exact lot‑specific calibrator values are encoded in the analyzer concerned, the respective application sheets, the product
    the barcode as well as printed on the enclosed (or electronically available) information and the Method Sheets of all necessary components (if
    calibrator barcode sheet. available in your country).
    Calibrator values A point (period/stop) is always used in this Method Sheet as the decimal
    Traceability: The Elecsys Prolactin II assay has been standardized using separator to mark the border between the integral and the fractional parts of
    the 3rd IRP WHO Reference Standard 84/500. a decimal numeral. Separators for thousands are not used.
    1 µIU/mL corresponds to 0.0472 ng/mL. Symbols
    Precautions and warnings Roche Diagnostics uses the following symbols and signs in addition to
    For in vitro diagnostic use. those listed in the ISO 15223‑1 standard (for USA: see
    Exercise the normal precautions required for handling all laboratory https://usdiagnostics.roche.com for definition of symbols used):
    reagents. Contents of kit
    Disposal of all waste material should be in accordance with local guidelines.
    Safety data sheet available for professional user on request. Analyzers/Instruments on which reagents can be used
    For USA: Caution: Federal law restricts this device to sale by or on the Reagent
    order of a physician.
    This kit contains components classified as follows in accordance with the Calibrator
    Regulation (EC) No. 1272/2008: Volume after reconstitution or mixing
    2-methyl-2H-isothiazol-3-one hydrochloride
    GTIN Global Trade Item Number
    EUH 208 May produce an allergic reaction.
    FOR US CUSTOMERS ONLY: LIMITED WARRANTY
    Product safety labeling follows EU GHS guidance.
    Roche Diagnostics warrants that this product will meet the specifications
    Avoid foam formation in all reagents and sample types (specimens, stated in the labeling when used in accordance with such labeling and will
    calibrators and controls).
    be free from defects in material and workmanship until the expiration date
    Handling printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
    Carefully dissolve the contents of one bottle by adding exactly 1.0 mL of OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
    distilled or deionized water and allow to stand closed for 15 minutes to WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
    reconstitute. Mix carefully, avoiding foam formation.
    PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
    Transfer aliquots of the reconstituted calibrators into empty labeled FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL
    snap‑cap bottles (CalSet Vials). Attach the supplied labels to the additional
    bottles. Store the aliquots immediately at ‑20 °C. DAMAGES.
    Perform only one calibration procedure per aliquot. COBAS, COBAS E and ELECSYS are trademarks of Roche.
    All other product names and trademarks are the property of their respective owners.
    Please note: Both the vial labels, and the additional labels (if available) Additions, deletions or changes are indicated by a change bar in the margin.
    contain 2 different barcodes. The barcode between the yellow markers is © 2016, Roche Diagnostics
    for cobas 8000 systems only. If using a cobas 8000 system, please turn
    the vial cap 180° into the correct position so the barcode can be read by the
    system. Place the vial on the instrument as usual.
    Storage and stability Roche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim
    Store at 2‑8 °C. www.roche.com
    The lyophilized calibrators are stable up to the stated expiration date. Distribution in USA by:
    Roche Diagnostics, Indianapolis, IN
    US Customer Technical Support 1-800-428-2336
    Stability of the reconstituted calibrators:
    at -20 °C 3 months (freeze only once)
    on the analyzers at 20-25 °C use only once
    Store calibrators upright in order to prevent the calibrator solution from
    adhering to the snap‑cap.

    2017-07, V 7.0 English 1/1

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