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BEDSIDE CONTROL CARD, ABO compatibility (Serafol)

https://unicat.msf.org/cat/product/19059
STD SSDTBLOC1--

Valid Article

Former Code(s): DDGTBLOC1--
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.
W01030309 - Combined abo typing + rhesus 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.
CT25
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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BEDSIDE CONTROL CARD, ABO (Serafol)

Definition

Test performed "at the patient's bedside" immediately prior to transfusion to verify ABO compatibility between the recipient blood and the unit to be transfused.

Specifications

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Technical specifications

  • Double plastic-coated card (105 x 73 mm) with dessicated reagents
  • clones: Anti-A 003/ Anti-B 005
  • 4 reaction zones: 2 anti-A and 2 anti-B
  • 1 donor side and 1 recipient side
  • Spots of dried monoclonal antibodies

Packaging & Labelling

Box of 50 control cards. Individual aluminium packaging per card

To be Ordered Separately

  • Transparent adhesive foils: 1 per card (packaged by 100), ref. BG1713
  • Mixing sticks: 4 per card (packaged by 100), ref BG1712
  • 1 safety lancet per card
  • 1 ampoule of physiological saline solution per card

Instructions for use

The ultimate pretransfusional control card allows preventing ABO incompatibility accidents resulting from blood unit or patient misidentification.

The control must be performed at the patient's bedside immediately prior to transfusion by the nurse or the medical doctor who performs the transfusion.

The ABO group of the recipient is verified from a capillary blood sample, and the one of the blood unit from a tubing segment.

This test is not a substitute for patient and donor ABO Rh D blood grouping or laboratory "cross-matching" test.

Keep the card in the patient's medical file after covering it with a transparent adhesive foil once it is dry.

Storage

  • Store between 2 and 25ºC
  • Do not freeze
  • Shelf life: 2 years
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
  • Not to be used beyond expiry date

(Cf Introduction: Thermosensitive products)

MSF requirements

Ultimate pretransfusional control using a bedside control card is compulsory.

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