(Erba XL200) XL MULTICAL 4x3ml, XSYS0034

STD ELAECCHC726

Valid Article

Former Code(s): SLASZNL0212
W0101050301 - Calibrators multicomponent (cc)
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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(Erba XL200) XL MULTICAL, XSYS0034

Definition

Lyophilized calibrator based on human serum used for calibration of clinical chemistry assays on Erba XL200 chemistry analyzer.

Specifications

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Technical specifications

Light yellow solid

Packaging & Labelling

4 x 3 ml

To be Ordered Separately

  • Quality controls
  • Reagents

Instructions for use

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Storage

  • Unreconstituted lyophilized calibrator is stable till the expiry date mentioned on the label when stored at 2–8°C.
  • Stability of the reconstituted calibrator*:
    • at 15–25 °C 8 hours
    • at 2–8 °C 2 days
    • at (-25) – (-15) °C 4 weeks (when frozen once)

*Exceptions:

  • Stability of Total Bilirubin in the reconstituted calibrator (when stored protected from light):
    • at 15–25 °C 6 hours
    • at 2–8 °C 1 day
    • at (-25) – (-15) °C 2 weeks (when frozen once)
  • ​​Stability of Direct Bilirubin in the reconstituted calibrator (when stored protected from light):
    • at 15–25 °C 3 hours
    • at 2–8 °C 8 hours
    • at (-25) – (-15) °C 2 weeks (when frozen once)
  • Store calibrator tightly capped and protected from light when not in use. Store vials upright to avoid spilts and leakage. Seal the vials tightly after use to prevent evaporation.

MSF requirements

Use with the Erba XL200

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