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(clinical chem. Piccolo) AMLYTE 13 PANEL, 400-0041

https://unicat.msf.org/cat/product/54011
STD ELAECCHT401

Valid Article

Former Code(s): -X DDGTZFR0240 DDGTZBE0234
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
W01010404 - Multiple parameters (mix of all) - clin. chem lab r.
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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(clinical chemistry Piccolo) AMLYTE 13

CAUTION

This article is worded and codified by unit to make the order easier but is always packaged in kit of 10.

Definition

The Piccolo AmLyte 13 panel, used with the Piccolo Xpress chemistry analyser, is a single cartridge in the form of a disk and provides in vitro quantitative determinations of 13 different clinical chemistry parameters.

Specifications

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Technical specifications

  • Unit-use self-calibrating plastic reagent disc: Piccolo AmLyte 13
  • 1 disc is aimed to perform the tests for 1 patient
  • Parameters
    • ALB: Albumin
    • ALT: Alanine Aminotransferase
    • AMY: Amylase
    • AST: Aspartate Aminotransferase
    • BUN: Blood Urea Nitrogen
    • Ca: Total Calcium
    • CK: Creatine Kinase
    • CRE: Creatinine
    • CRP: C-Reactive Protein
    • GLU: Glucose
    • K+: Potassium
    • Na+: Sodium
    • TBIL: Total Bilirubin
  • Sample volume: 100 µl
  • Sample type: serum, plasma, whole blood (collected with lithium heparin only)
  • Test duration: approx. 12 minutes

Packaging & Labelling

Box of 10 discs, ref. 400-0041 (one Piccolo Amlyte 13 disc ref. 400-1041)

To be Ordered Separately

  • Controls: low and high
  • Sample tranfert pipettes and tips

(see related items)

Instructions for use

Follow instructions on package insert and/or operating manual.

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.

Precautions for Use

  • Do not reuse a disk even if operation was interrupted.
  • Never use a disk that was dropped or cracked, as it may spread biohazardous material through the interior of the analyser, and it can affect the results.
  • A disc not used within 20 minutes of opening the pouch should be discarded.

Storage

  • Keep refrigerated between 2 and 8°C, Protect from sunlight
  • Do not expose opened or unopened discs to direct sunlight or temperatures above 32°C
  • When taking out of the refrigerator, condensation can appear. The disks can stay 48 hours at ambient temperature.
  • Do not freeze
  • Shelf life: min 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

Image

Signal Word

Warning

H302Harmful if swallowed
H315Causes skin irritation
H335May cause respiratory irritation
EUH401To avoid risks to human health and the environment, comply with the instructions for use.
P235Keep cool.
P273Avoid release to the environment
P308 + P313IF exposed or concerned: Get medical advice/attention.
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