(spectrophotometer) KIT, CHOLESTEROL complete, 4x30 ml 10017

STD ELAESPET10017

Valid Article

Former Code(s): SLASZTF0364 DDGTSPEP102
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.
20
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01010205 - Cholesterol
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, CHOLESTEROL

Definition

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

Specifications

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Components

Complete test kit:

  • 4 x 30 ml Enzyme reagents (RGT)
    • Phosphate buffer (pH 6.5) 30 mmol/l
    • 4-Aminoantipyrine 0.3 mmol/l
    • Phenol 5 mmol/l
    • Peroxidase ≥ 5 KU/l
    • Cholesterolesterase ≥ 150 U/l
    • Cholesteroloxidase ≥ 100 U/l
    • Sodium azide 0.05 %
  • 3ml standard (STD)
    • Cholesterol see label
    • Sodium azide 0.095%

Technical specifications

  • Complete kit for 120 measurements (controls, standard, samples) with enzyme reagents
  • CHOD - PAP method, Enzymatic colorimetric test with lipid clearing factor
  • Ready to use reagent and standard

Packaging & Labelling

Kit of 4 vials of 30 ml and one vial of 3 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.

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Storage

  • Keep refrigerated between 2 and 8ºC (if openend reagent is stored at 15-25°C, it is stable for 2 weeks)
  • Do not freeze
  • Shelf life: 20 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).

Signal Word

Standard : Warning

H317May cause an allergic skin reaction
H319Causes serious eye irritation
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
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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