(spectrophotometer) KIT, HDL CHOLESTEROL liquic.80 ml 10084

STD ELAESPET10084

Valid Article

Former Code(s): DDGTSPEP104

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, HDL CHOLESTEROL

Definition

Kit of reagents for the quantitative determination of HDL cholesterol in a blood sample (serum, heparinised or EDTA plasma) with the use of a spectrophotometer.

Specifications

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Components

Kit HDL Cholesterol

  • 1 x 60 ml Enzymes (ENZ)
    • Good's buffer, pH 6.6 100 mmol/l
    • Sodium chloride 170 mmol/l
    • Cholesterol esterase 1400 U/l
    • Cholesterol oxidase 800 U/l
    • Catalase 600 kU/l
    • Ascorbate oxidase 3000 U/l
    • (HDAOS) 0.56 mmol/l
    • Preservative 0.1 % w/v
  • 1 x 20 ml Substrate (SUB)
    • Peroxidase 3500 U/l
    • 4-Aminoantipyrin 4 mmol/l
    • Good's buffer, pH 7.0 100 mmol/l
    • Preservative 0.1 % w/v
    • Detergents 1.4 % w/v
    • Sodium azide 0.05 % w/v
  • 1 Calibrator (CAL) to reconstitute with 4 ml of distilled water

Technical specifications

  • Complete kit for 80 measurements (controls, calibrator, samples)
  • Enzymatic colorimetric test
  • ENZ (R1) and SUB (R2) are ready for use
  • Enzyme: colourless fluid
  • Substrate: yellowish fluid

Packaging & Labelling

  • Kit HDL Cholesterol
    • 1 vial of 60 ml, 1 vial of 20 ml and 1 vial of 5 ml

Transport Dangerous Goods

Transport not regulated

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
  • Do not freeze
  • Shelf life: 20 months.
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • After opening, ENZ and SUB reagents are stable for 2 months at 2 to 8°C. Protect enzyme from light
  • CAL is stable 8 hours at 25°C, 7 days at 2 to 8°C or 20 days at -20°C after reconstitution
  • 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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