BLOOD GROUPING TEST, anti A (BIOSCOT), 10 ml, dropper bot.

STD SSDTBLOG3A-

Valid Article

Former Code(s): DDGTBLOG3A-
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.
W01030301 - Abo typing
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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BLOOD GROUPING TEST, anti A (BIOSCOT)

Definition

ABO reagents contain immunoglobulins used for the blood group typing by determining the presence or absence of A and/or B antigens on the red cells.

The anti-A immunoglobulins are capable of binding to specific antigenes. This reagent is intended to be used in testing a clinical specimen for group A red blood cell antigens, using an agglutination method (clumping).

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

Specifications

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Components

  • Murine monoclonal antibodies
  • preservative agent: 0.1% (w/v) sodium azide

Technical specifications

  • Blue reagent
  • Labellised dropping bottles

Packaging & Labelling

10 x10 ml dropper bottles intended for about 150-200 tests each

Instructions for use

Follow the instructions of the package insert.

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

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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