(HA Sysmex KX21-XP300-XQ320) STROMATOLYSER, 3 x 500ml

STD ELAEHAAC102

Valid Article

Former Code(s): -X SLASHANA102 DDGTZYN1004
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
W0103010105 - Cbc-reagents (cleaning-/diluting-/lysing-/sheat-fluids)
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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(HA SYSMEX KX21-XP300-XQ320) SOLUTIONS

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Definition

Solutions for Sysmex analyzer KX21, XP300 or XQ320

Specifications

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Components

  • Cellclean: solution sodium hypochlorite
  • Stromatolyser: dodecyltrimethylammonium-chloride and trimethyloctadecylammonium-chloride

Packaging & Labelling

  • Cell clean solution, 50 ml, bottle
  • Stromatolyser, 3 x 500 ml bottle
  • Cell pack, 20 l bottle

Transport Dangerous Goods

Cell clean solution, 50 ml bottle

  • UN1791
  • Class: 8
  • Packing group: II
  • Proper shipping name: Hypochlorite solution

Instructions for use

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.

Precautions for Use

Cell clean solution: international transportation regulated

  • UN1791
  • Requires a specific packaging until the final destination

Storage

  • Cell clean solution: store between 15 and 30ºC
  • Stromatolyser: store between 2 and 35°C
  • Cell pack: store between 5 and 30°C
  • Shelf life
    • Cell clean solution: 12 months
    • Stromalyser: 12 months
    • Cell pack: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Shelf life after opening
    • Stromalyser: 90 days
    • Cell pack: 60 days

(Cf Introduction: Thermosensitive products)

Cellclean:

  • Aquatic acute 1, H400
  • Aquatic chronic 2, H411
  • Eye damage 1, H318
  • Skin corrosion 1, H314
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Signal Word

Cellclean: Danger

H314Causes severe skin burns and eye damage.
H410Very toxic to aquatic life with long lasting effects
EUH031Contact with acids liberates toxic gas.
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P273Avoid release to the environment
P280Wear protective gloves/protective clothing/eye protection/face protection
P310Immediately call a POISON CENTER or doctor/physician.
P391Collect spillage
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
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