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  3. CEFTRIAXONE, 30μg, clsi, eucast, disc [OXD-CT0417B]
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CEFTRIAXONE, 30μg, clsi, eucast, disc [OXD-CT0417B]

https://unicat.msf.org/cat/product/75318
STD SASTDISCCROO

Valid Article

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.
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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CEFTRIAXONE, 30μg, clsi, eucast [Oxoid]

CAUTION

This article is worded and codified by unit to make the order easier, but is always packaged in kit of 250 discs

Definition

A susceptibility testing disc impregnated with a defined amount of a specific antibacterial is intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using an agar diffusion method.

Specifications

  • CEFTRIAXONE, 30 μg
  • Code: CRO
  • clsi
  • eucast
  • Compatibility with disc dispensor
  • 1st choice
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Quality Standards Comment

This method is based on a standardized procedure published by the WHO and adopted as consensual standard by the CLSI (Clinical and Laboratory Standard Institute), CA-SFM (Comité de l'Antibiogramme, Société Française de Microbiologie), and EUCAST (European Committee on Antimicrobial Susceptibility Testing).

Technical specifications

  • 6 mm filter paper discs
  • Absorbent paper impregnated with precise concentrations of antimicrobial agents
  • The discs are clearly identified by a code: 1 to 3 letters for the antimicrobial agent and 1 to 3 figures for the concentration of the antimicrobial agent, printed on each side of the disc
  • Discs dispenser needs ideally to be from the same brand as the discs to fit the cartridges

Packaging & Labelling

  • 5 x 50 discs.
  • Cartridges are individually packed in a foil-sealed blister pack with a desiccant

Transport Dangerous Goods

Transport not regulated

To be Ordered Separately

  • Discs dispenser: must be from the same brand as the discs. Only discs from Oxoid are compatible with the disc dispensor (Oxoid). Discs from other brands need to be placed manually on the plate using a forceps.
  • Culture media
  • Bacterial strains for quality control
  • Densitometer

Instructions for use

  • Follow the instructions in the leaflet.
  • Follow the instruction of the current guidelines (CLSI, CA-SFM, EUCAST).
  • Susceptibility testing quality controls should be done with the quality control strains detailed in the SBQC chapter, with the frequency described in the SOP.

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

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

  • Shelf life : 36 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life.
  • Not to be used beyond the expiry date
  • Unopened cartridges must be stored at -20°C to 8°C. Unopened cartridges should be allowed to come to room temperature before removing them from the packaging to minimize condensation as this may reduce the potency of the antimicrobial agent.
  • Once the cartridges are open they need to be stored within the dispenser in the container provided with a charged desiccant, or other suitable opaque air tight container with a charged desiccant to protect the discs from moisture.
  • Dispensers should be stored within the container in the refrigerator.
  • Once a cartridge is open, it is recommended that it is stored for no more than 7 days.

(Cf Introduction: Thermosensitive products)

Waste management

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

Classification EC Regulation N° 1272/2008

Not classified as hazardous

MSF requirements

Reserved to bacteriology programmes.

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