(Erba XL200) REAGENT KIT BILIRUBIN TOTAL XSYS0023

STD ELAECCHC707

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CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
W01010203 - Bilirubin
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) REAGENT KIT BILIRUBIN TOTAL XSYS0023

Definition

Reagent for quantitative in vitro determination of Bilirubin Total (Walter & Gerard method) in human serum and plasma using an Erba XL chemistry automate.

Specifications

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Components

  • R1: 6 vials (44 ml)
  • R2: 6 vials (11 ml)

Technical specifications

  • R1 and R2: Clear colourless liquids
  • 1200 tests

Packaging & Labelling

R1: 6 x 44 ml - R2: 6 x 11 ml

To be Ordered Separately

  • Quality controls
  • Calibrators

Instructions for use

Before opening let R1 equilibrate for 10 minutes at room temperature

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Storage

  • The unopened reagents are stable till the expiry date stated on the bottle and kit label when stored at 2–8 °C. Before opening let R1 equilibrate for 10 minutes at room temperature.
  • On board stability: min. 30 days if refrigerated (2–10 °C) and not contaminated.

Waste management

Substance with hazardous characteristics. Please contact your watsan referent for advice on proper disposal.

Detailed hazard and precautionary information can be found in the safety data sheet (SDS).

Classification EC Regulation N° 1272/2008

R1:

  • Skin Corr. 1, H314
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Danger

H314Causes severe skin burns and eye damage.
H318Causes serious eye damage.
EUH208supplied by the manufacturer. Comply with the safety instructions. Contains (name of sensitising substance). May produce an allergic reaction. Contains (name of sensitising substance). May produce an allergic reaction.
P280Wear protective gloves/protective clothing/eye protection/face protection
P301 + P330 + P331IF SWALLOWED: rinse mouth. Do NOT induce vomiting
P303 + P361 + P353IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing.
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
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