URINE TEST, pH,bili,prot,gluc,ket,blood,nit,leuc, 1 strip

STD SSDTURIS8--

Valid Article

Former Code(s): DDGTURIS1M-
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.
15
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0101060204 - Urine multi-constituent test strips (manual)
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.
The order of this product needs to be justified and is only acceptable under certain conditions.
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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URINE TEST, pH, bili, prot, gluc, ket, blood, nit, leuc

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 50.

Definition

Test used for the determination of 8 parametres in urine: pH, bilirubin, proteins, glucose, ketones, blood, nitrites and leukocytes.

Specifications

Components

  • Plastic box with colorimetric charts
  • Silicagel sachet
  • 50 strips for single use

Technical specifications

  • Strip with 8 reagent pads which change colour according to the concentration of substances in urine.
  • Parameters: pH, bilirunin, protein, glucose, ketone, blood, nitrite, leukocyte
  • Colorimetric chart giving semi-quantitative results: -, ±, +, ++, +++, ++++ and mmol/L and mg/dl results.

Caution: Semi-quantitative result ranges may differ between different brands of tests.

Packaging & Labelling

Kit of 50 tests

Instructions for use

Follow the instructions in the leaflet.

Close the box tightly after each use since the test quickly deteriorates with humidity.

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 between 2ºC and 30ºC, Protect from sunlight ‐ Protect from humidity
  • Shelf life: 15 to 24 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Not to be used beyond expiry date

MSF requirements

These parameters allow the biological follow-up of urinary and genital tract infections, nephrotic syndroms and glucide metabolism problems.

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