(Erba XL200) CONTROL REAGENT ERBA PATH, 4x5ml BLT00081

STD ELAECCHC709

Valid Article


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.
W01010501 - Multicomponent controls (clinical chemistry)
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.

OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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(Erba XL200) CONTROL REAGENT, normal and pathological

Definition

Control sera, normal and pathological, to be used with an Erba XL chemistry automate.

Specifications

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Components

  • Human serum
  • Chemical additives
  • Tissue extracts of human and animal origin
  • Bacteriostatic agents

Technical specifications

  • Lyophilised
  • White, yellow solid

Packaging & Labelling

  • Erba Norm: 4 x 5 ml
  • Erba Path: 4 x 5 ml

Transport Dangerous Goods

Transport not regulated

Instructions for use

Storage

Prior to reconstitution:

  • The control should be stored at 2–8°C and is stable till the expiry date printed on the label.
  • Protect from light.

After reconstitution:

  • The constituents when protected from light and contamination are stable:
    • 1 day at 18–25°C
    • 1 week at 2–8°C (Bilirubin: 1 day)
    • 1 month at –20 °C

Waste management

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

Not classified as hazardous

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