(spectrophotometer) KIT, ALP 16x4ml + 1x16ml 12217

STD ELAESPET12217

Valid Article

Former Code(s): DDGTSPEP107
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.
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01010105 - Alkaline phosphatase - 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.
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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(spectrophotometer) KIT, ALP

Definition

Kit of reagents to determine the dosage of alkaline phosphatase (ALP) in a blood sample (serum or heparinised blood) with the use of a spectrophotometer.

Specifications

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Components

  • 16 x 4 ml Buffer (BUF)
  • 1 x 16 ml Substrate (SUB)

Technical specifications

  • Complete kit for 80 measurements (controls, standard, samples)

Packaging & Labelling

Kit of 16 vials of 4 ml and 1 vial of 16 ml

To be Ordered Separately

Lyophylised control Serodos (Human) normal range and Serodos Plus (Human) abnormal range (see related articles below)

Instructions for use

Follow the instructions in the package insert.

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

  • Keep refrigerated between 2 and 8ºC
  • Do not freeze
  • Shelf life: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Not to be used beyond expiry date

(Cf Introduction: Thermosensitive products)

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

  • Specific target organ toxicity, repeated exposure, Category 2, H373
  • Skin Irritation, Category 2, H315
  • Eye Irritation, Category 2, H319
  • Skin Sensitivity. Category 1, H317
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Signal Word

Warning

H315Causes skin irritation
H317May cause an allergic skin reaction
H319Causes serious eye irritation
H373May cause damage to organs (or state all organs affected, if known) through prolonged or repeated exposure (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P280Wear protective gloves/protective clothing/eye protection/face protection
P321Specific treatment (see ... on this label)
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations
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