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

STD ELAEELIT101

Valid Article

Former Code(s): DDGTELIS101
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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.
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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)
  • 1 Adhesive strip

Technical specifications

  • Kit for 96 tests
  • 1 ELISA microtiterplate

Packaging & Labelling

Transport dangerous goods

  • UN3264
  • Hazard Class: 8
  • Packing group: III
  • Proper Shipping Name: Corrosive liquid, acidic, inorganic, n.o.s

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)

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