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BLOOD GROUPING TEST, RHESUS anti D (BIOSCOT), 10ml, dr.bot

https://unicat.msf.org/cat/product/19074
STD SSDTBLOG3D-

Valid Article

Former Code(s): DDGTBLOR3D- SSDTBLOR3D-
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.
W0103030201 - Rhesus d
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.
S
The order of this product needs to be justified and is only acceptable under certain conditions.
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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BLOOD GROUPING TEST, RHESUS anti D (BIOSCOT)

Definition

Reagents containing immunoglobulines used in the blood rhesus typing. The immunoglobulins capable of binding to specific antigenic determinants. This reagent is intended to be used in testing a clinical specimen for Rh(D) red blood cell antigens from the rhesus system, using an agglutination method (clumping).

Used together with the anti-A, anti-B, anti-AB and Rhesus negative blood grouping reagents.

Specifications

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Components

  • Murine monoclonal antibodies, chemical potentiators and bovine material
  • Preservative agent: 0.1% (w/v) sodium azide

Technical specifications

  • Colorless, limpid reagent
  • Labelised dropper bottles
  • IgM monoclonal antibody; clone RUM-1

Packaging & Labelling

10 x 10 ml dropper bottles, intended for about 150 - 200 tests

Instructions for use

Follow the instructions in the leaflet.

Perform the agglutination test on an opaline plate or a porcelain tile, or in default of this, on a slide.

Most examples of D weak and partial D red cells are detected.

Storage

  • Keep refrigerated between 2º and 8ºC
  • Do not freeze
  • Shelf life: 36 months
  • Not to be used beyond expiry date
  • Close the bottle tightly after each use to prevent bacterial contaminations (causing the deterioration of the serum-test). In case of doubt concerning the serum-test validity, perform a check on a known blood, fresh or kept in good conditions (2º - 8ºC).

(Cf Introduction: Thermosensitive products)

MSF requirements

The 5 reagents for blood grouping (anti-AB, anti-A, anti-B, anti Rh D, Rhesus negative control) must all come from the same manufacturer. This is the reason why we close the article to 1 manufacturer.

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