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(spectrophotometer) KIT, P-AMYLASE 4 x 10 ml 12009

https://unicat.msf.org/cat/product/13509
STD ELAESPET12009

Valid Article

Former Code(s): DDGTSPEP112
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
W01010107 - Amylase - 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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(spectrophotometer) KIT, P-AMYLASE

Definition

Kit of reagents to determine the dosage of pancreas-amylase in a blood sample (serum, heparinised or EDTA plasma) or urine with the use of a spectrophotometer.

Specifications

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Components

  • 4 x 10 ml Buffer (BUF)
  • 2 x 5 ml Substrate reagent (SUB)

Technical specifications

  • Complete kit for 40 measurements (controls, standard, samples)
  • Enzymatic colorimetric quantitative test (405 nm)

Packaging & Labelling

Kit of 4 vials of 10 ml and 2 vials of 5 ml

To be Ordered Separately

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

Lyophilised calibrator (AUTOCAL) should be ordered separately (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.

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Storage

  • Keep refrigerated between 2 and 8ºC
  • Do not freeze
  • Shelf life: 12 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)

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