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BETA-LACTAMASE TEST, cefinase, disk [BD-231650]

https://unicat.msf.org/cat/product/56613
STD SASTIDSCBLAC

Valid Article

Former Code(s): SLASZBD0130 SLASZBE0579 SBIDIDSCBLAC
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.
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0104080502 - Impregnated disks, multi-disks & tablets
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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
FSRT
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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BETA-LACTAMASE TEST, disc

CAUTION

This disc is worded and codified by unit to make the order easier, but it is always packaged in kit of 50 discs.

Definition

Cefinase discs are used for use in rapid detection of ß-lactamase enzyme production of Neisseriagonorrhoeae, Staphylococcus species, Haemophilusinfluenzae, enterococci and anaerobic bacteria, isolated from a clinical specimen.

Specifications

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Technical specifications

Cefinase paper discs impregnated with nitrocefin.

Packaging & Labelling

Cartridge of 50 discs.

Instructions for use

Please consult the “Bacteriology laboratory procedures and resources” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Bacteriology-Laboratory-Resources.aspx

For offline access, contact your laboratory advisor

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Precautions for Use

All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Follow the recommendations of the manufacturer for the storage (between -20°C to +8°C).
  • After use, the cartridge should be stored in a glass, air tight container with dessicant at -20°C to +8°C.
  • Can be used 60 days after opening blister packaging.
  • Do not use after expiry date.
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
  • Do not use if the discs appear orange or red in colour.

(Cf Introduction: Thermosensitive products)

Waste management

After use, sterilize the cultures and all contaminated material. Please contact your watsan referent for advice on proper disposal.

MSF requirements

Reserved for bacteriology programmes.

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