TEST, HEPATITIS E (Assure HEV), ser/pl/wb, 1 test 43160-020

STD SSDTHETE20T

Valid Article

Former Code(s): -X DDGTZFR0152 DDGTZBE0200 DDGTZNL0178
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.
23
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01050902 - Hepatitis viruses - rt & poc
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.
The order of this product needs to be justified and is only acceptable under certain conditions.
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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HEPATITIS E TEST (Assure HEV)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 20.

Definition

Rapid immunochromatographic test intended for the qualitative detection of IgM antibodies to Hepatitis E virus (HEV) in human serum, plasma or whole blood.

Due to performance limitations, the test is validated for investigation of epidemics, and not for individual diagnosis of Hepatitis E.

Specifications

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Components

  • 20 x HEV IgM Rapid Test devices in individually sealed pouches with desiccant.
  • 1 x (5 ml) chase buffer: containing 0.02% thimerosal and 0.01% Triton-X 100.
  • 20 x plastic sample applicators: each with marks at 25µl and 35µl
  • Instructions For Use

Technical specifications

  • Sample volume: 25μl serum, plasma and 35μl whole blood
  • Sample type: serum, plasma and whole blood collected with anticoagulant
  • Time: 15 min

Packaging & Labelling

Box of 20 individually sealed pouches each containing a test with desiccant.

To be Ordered Separately

  • Safety blood lancet
  • Alcohol swabs

Instructions for use

Use on serum, plasma or whole blood.

Follow the instructions on in the leaflet.

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Precautions for Use

All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsary wearing of gloves, hand washing, etc.)

Storage

  • Store between 2-28°C
  • Test devices should be kept sealed until use
  • Not to be used beyond expiry date
  • Shelf life: 23 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

Waste management

Presence of mercury in the reagents as thimerosal 0.02%. Please contact your watsan referent for advice on proper disposal.

Detailed hazard and precautionary information can be found in the safety data sheet (SDS).

Chase buffer containing 0.02% thimerosal and 0.01% Triton-X 100.

Signal Word

Warning

Image
H319Causes serious eye irritation
P264Wash … thoroughly after handling
P280Wear protective gloves/protective clothing/eye protection/face protection

MSF requirements

Due to performance limitations, the test is intended for investigation of epidemics only, and not for individual diagnosisof Hepatitis E.

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