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(ELISA) KIT TSH, plate 96 tests (Human 54030)

https://unicat.msf.org/cat/product/13351
STD ELAEELIT101

Valid Article

Former Code(s): -X DDGTELIS101
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.
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01020410 - Thyroid stimulating hormone
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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(ELISA) KIT TSH

Definition

Reagents for the determination of thyroid stimulating hormone (TSH) by ELISA test in a blood sample (serum).

TSH determination allows to diagnose hypothyroidism in TB patients receiving second-line drugs.

Specifications

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Components

  • 12 Microtiter strips (MIC)
  • Calibrators (CAL)
  • 13 ml Enzyme conjugate (CON)
  • 50 ml Wash solution (WS)
  • 13 ml Substrate reagent (SUB)
  • 15 ml Stop solution (STOP) - sulfuric acid
  • 1 Adhesive strip

Technical specifications

  • Kit for 96 tests
  • 1 ELISA microtiterplate
  • Calibrators, wash solution, substrate reagent, stop solution : colourless liquids
  • Enzyme conjugate: red liquid

Instructions for use

Follow 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 - 8ºC
  • Do not freeze
  • Shelf life: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

(Cf Introduction: Thermosensitive products)

Classification EC Regulation N° 1272/2008

Stop solution:

  • Skin irritation 2, H315
  • Eye irritation 2, H319

"2nd product" indicates P statement for : calibrators/enzyme conjugate/wash solution/substrate

Image

Signal Word

Stop solution: Warning

H315Causes skin irritation
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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