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QUALITY CONTROL STRAINS KIT n°1 [MBL-MSF KIT 1]

https://unicat.msf.org/cat/product/76595
STD SBQCKWIKCOK1

Valid Article

Former Code(s): SBQCKWIKCORE1
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.
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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QUALITY CONTROL STRAINS KIT (MINILAB)

Definition

Microorganism strains used as controls to verify the performance of assays, reagents or media used in microbial testing for the detection and identification of a cultured microorganism isolate.

Each strain contains a pellet of lyophilised micro-organism, an ampoule of hydrating fluid and inoculating swab.

Each kit is designed to contain the recommended quality control strains for a particular test method, assay or regulatory standard.

Specifications

  • Traceable to the American Type Culture Collection (ATCC®) or other authentic reference culture collections
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Components

Pellets composed of a pure population of microorganisms associated with excipients for structure or stability, such as gelatin, skimmed milk, ascorbic acid, carbohydrate and coal.

MSF KIT 1, strains included:

  • (QC routine) ATCC 25922, E COLI
  • (QC resist ESBL) ATCC 700603, K PNEUMONIAE
  • (QC resist Vanco) ATCC 51299, E FAECALIS
  • (QC training) ATCC 19606, A BAUMANNII
  • (QC routine) ATCC 29213, S AUREUS
  • (QC training) ATCC 13813, S AGALACTIAE

MSF KIT 2, strains included:

  • (QC resist MRSA) NCTC 12493, S AUREUS
  • (QC routine) ATCC 49766, H INFLUENZAE
  • (QC routine) ATCC 29212, E FAECALIS
  • (QC resist Colistin) NCTC 13846, E COLI
  • (QC resist KPC) ATCC BAA-1705, K PNEUMONIAE
  • (QC routine) ATCC 27853, P AERUGINOSA

MSF KIT TRAINING, strains included:

  • (QC training) ATCC 10231,C ALBICANS
  • (QC training) ATCC 15305, S SAPROPHYTICUS
  • (QC routine) ATCC 49619, S PNEUMONIAE
  • (QC training) ATCC 19115, L MONOCYTOGENES

Technical specifications

  • Ready to use lyophilized pellets
  • Each unit is sealed in a plastic bag containing a desiccant to prevent the appearance of unwanted moisture.
  • Strains are less than or equal to three passages from reference culture
  • Traceability to reference cultures ensures authenticity

Packaging & Labelling

Pack of 2 or 6

To be Ordered Separately

Agar medium, non-selective, nutritious or supplemented

Instructions for use

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

For offline access, contact your laboratory advisor

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Storage

  • Store between 2°C and 8°C
  • Do not freeze
  • Store in the original, sealed bottle or in the sachet containing the desiccant.
  • Microorganisms should not be used if:
    • storage in poor conditions;
    • evidence of excessive exposure to heat or humidity;
    • exceeding the expiration date
  • Shelflife: 24 months

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).

MSF requirements

Reserved for projects using the Mini-Lab

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