(spectrophotometer) KIT, ASAT, IFCC 16x4ml + 1x16ml 12211

STD ELAESPET12211

Valid Article

Former Code(s): DDGTSPEPAST
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
W01010110 - Aspartate amino-transferase
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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(spectrophotometer) KIT, ASAT / GOT

Definition

Kit of reagents to determine the dosage of aspartat-aminotransferase/ glutamat-oxalacetat transaminase (ASAT/GOT) in serum, heparinised and EDTA plasma with the use of a spectrophotometer.

Specifications

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Components

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

Technical specifications

  • Complete kit for 80 measurements (controls, standard, samples)
  • Controls should be ordered separately

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 8°C
  • Do not freeze
  • Keep protected from light
  • Shelf life: 15 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)

P401Store in accordance with local and regional/ national/ international regulations
P234Keep only in original container.
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P262Do not get in eyes, on skin, or on clothing.
P281Use personal protective equipment as required.
P303 + P361 + P353IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing.
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P337 + P313If eye irritation persists: get medical advice/attention
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations
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