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(Erba XL200) REAGENT CREATININE KINASE XSYS0022

https://unicat.msf.org/cat/product/70140
NST ELAECCHC710

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.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01010113 - Creatine kinase - total
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.
0208
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) REAGENT CREATININE KINASE XSYS0022

Definition

Reagent for quantitative in vitro determination of creatinine kinase (IFCC & DGKCH method) in human serum and plasma using an Erba XL chemistry automate.

Specifications

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Components

2 vials R1 (44 ml) + 2 vials R2 (11 ml)

Technical specifications

  • R1 and R2: colourless and odourless liquids
  • 500 tests

Packaging & Labelling

R1: 2 x 44 ml - R2: 2 x 11 ml

To be Ordered Separately

  • Quality controls
  • Calibrators

Instructions for use

Storage

  • The unopened reagents are stable till the expiry date stated on the bottle and kit label when stored at 2–8°C.
  • On board stability: minimum 30 days if refrigerated (2–10°C) and not contaminated.
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

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 and R2) Repr. 1B, H360D

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Signal Word

Danger

H360DMay damage the unborn child
P201Obtain special instructions before use.
P280Wear protective gloves/protective clothing/eye protection/face protection
P308 + P313IF exposed or concerned: Get medical advice/attention.

Signal Word

Danger

MSF requirements

Use with the Erba XL200

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