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(QC resist ESBL)ATCC 700603/NCTC 13368,K PNEUMONIAE,5pellets

https://unicat.msf.org/cat/product/45490
STD SBQCPELTKLPN2

Valid Article

Former Code(s): SLASZFR0432 SBQCPELTKLPN3
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.
16
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W01040601 - Qc strains bacteriology
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.
UN3373
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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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RESISTANCE QUALITY CONTROL MICROORGANISM

Definition

Phenotypically characterized resistant strains that are developped according to the recommendation of/made available by the European Society of Clinical Microbiology and Infectious Diseases (EUCAST) for quality control.

The microbial strains have specific resistance mechanisms (ESBL, MRSA, ...) and phenotypically reproducible levels of susceptibility.

They are lyophilized into pellets.

The microbial strain preparations are derived from ATCC® (American Type Culture Collection), NCTC® (National Collection of Type Cultures, operated by the UK Health Security Agency (UKHSA)

Specifications

  • ATCC 700603/NCTC 13368 KLEBSIELLA PNEUMONIAE:
    • ESBL (Extended-Spectrum β-Lactamase) production in Enterobacteriaceae
  • NTCT 12493 S AUREUS:
    • methicillin resistance in Staphylococcus aureus
  • ATCC 51299 ENTEROCOCCUS FAECALIS:
    • vanB-mediated glycopeptide resistance in enterococci
    • high-level aminoglycoside resistance in enterococci
  • ATCC 49247 HAEMOPHILUS INFLUENZA:
    • reduced susceptibility to ß-lactam agents due to PBP mutations in Haemophilus influenzae
  • ATCC BAA-1705 KLEBSIELLA PNEUMONIAE:
    • carbapenemase producer
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Quality Standards Comment

EUCAST recommendations - version 8

Components

The quality control microorganisms are packaged in a resealable vial that contains five lyophilized pellets of a single microorganism strain and a desiccant to prevent adverse accumulation of moisture

Technical specifications

  • Freeze dried bacterial strains
  • ATCC: Each lyophilized microorganism preparation is less than or equal to four (4) passages from a reference culture.
  • NCTC: Each lyophilized microorganism preparation is one (1) passage from the reference NCTC culture.
  • Microorganisms for standard protocols should be used within five passages of the ATCC reference culture.

Packaging & Labelling

1 vial contains 5 lyophilized pellets

Transport Dangerous Goods

  • UN3373
  • Class 6.2
  • Proper shipping name: Biological substance, Category B

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

  • Store between 2°C and 8°C, with desiccant
  • Store at -20°C to -80°C after suspension in brain heart infusion broth and glycerol
  • Do not use after expiry date
  • Shelf life
    • ATCC: 16 months
    • NCTC: 24 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

(Cf Introduction: Thermosensitive products)

Waste management

After use, sterilize the cultures and all contaminated material

Substance with biohazardous characteristics. Please contact your watsan referent for advice on proper disposal.

Detailed hazard and precautionary information can be found in the safety data sheet (SDS).

Image

Signal Word

Biohazard

MSF requirements

Reserved for bacteriology programmes

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