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RH NEGATIVE CONTROL (Lorne),monoclonal antibodies, 10ml, bot

https://unicat.msf.org/cat/product/19068
STD SSDTBLOG1C-

Valid Article

Former Code(s): DDGTBLOG2C- SSDTBLOG2C-
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.
W01030304 - Immunohaematology controls
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.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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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RH NEGATIVE CONTROL (Lorne)

Definition

Negative control for monoclonal anti-D reagents, used to detect false positive reactions during ABO/rhesus blood grouping tests.

Used together with the anti-A, anti-B, anti-AB, anti Rh D grouping reagents.

Specifications

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Components

  • Proteins, additives and potentiators (no antibodies)
  • Preservative agent: sodium azide

Technical specifications

Colourless reagent

Packaging & Labelling

10 ml dropper bottle, intended for 150 to 200 tests

Instructions for use

Follow the instructions in the leaflet.

The purpose of this reagent is to detect red cell autoagglutination that can give false-positive reactions with the anti-A, anti-B, anti-AB and rhesus anti-D blood grouping reagents.

It should be used as a negative control for all ABO/Rh blood grouping tests.

A positive reaction indicates that the specimen is reacting with the reagents' components and not with the antibodies.

A negative reaction offers assurance that the positive result obtained with anti-D reagents is due to a specific antigen-antibody reaction.

Storage

  • Keep refrigerated between 2 and 8ºC
  • Do not freeze
  • Shelf life: 30 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).

(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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