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RH NEGATIVE CONTROL,monocl. antibodies (BIOSCOT), 10ml,bot

https://unicat.msf.org/cat/product/19072
STD SSDTBLOG3C-

Valid Article

Former Code(s): DDGTBLOG3C-
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.
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.
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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RH NEGATIVE CONTROL (BIOSCOT)

Definition

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

Specifications

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Components

  • Buffer solution containing chemical potentiators (no antibodies) and bovine material
  • Preservative agent: 0.1% (w/v) sodium azide

Technical specifications

  • Colourless reagent
  • Labellised bottles

Packaging & Labelling

10x 10 ml dropper bottles intended for about 125 tests

Instructions for use

Follow the instructions in the package insert.

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

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 2º and 8ºC
  • Do not freeze
  • Shelf life: 48 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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