(creatinine StatSensor Xpress-i) CREATININE STRIP 43272

STD ELAECRET101

Valid Article

Former Code(s): DDGTMISC205- DDGTZFR0205 ELAECRET202
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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
W0101060112 - Creatinine analysis test strips
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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(creatinine Nova StatSensor) STRIPS

Definition

Single use strips to be used with the Nova StatSensor® Xpress-iTM Creatinine analyser.

Specifications

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Technical specifications

  • Test strip volume: 1.2 µl
  • Creatinine measurement range: 27-1056 µmol/l or 0.3-12.0 mg/dl
  • Test time: 30 seconds
  • Single use

Packaging & Labelling

Box containing 2 vial of 25 test strips

Instructions for use

Follow the manufacturer's instructions for use.

Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx

For offline access, contact your laboratory advisor.

Storage

  • Store in the original vial
  • Keep refrigerated between 2-8°C
  • Do not freeze
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

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