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(API System) 20NE STRIP, non-Enterobacteriaceae [BMX-20050]

https://unicat.msf.org/cat/product/51495
STD SBIDAPIS20NE

Valid Article

Former Code(s): SLASZBD0100 SLASZBE0548
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.
11
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W0104080209 - Manual identification kits - anaerobes, pathogens - other
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.
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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API 20 NE STRIPS, non-Enterobactreriaceae

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25 strips.

Definition

API 20 NE is a standardized system for the identification of non-fastidious, non-enteric Gram-negative rods (e.g. Pseudomonas, Acinetobacter, Flavobacterium, Moraxella, Vibrio, Aeromonas, etc.), combining 8 conventional tests, 12 assimilation tests and a database.

Specifications

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Components

Kit of 25 tests:

  • 25 API 20 NE strips
  • 25 incubation boxes
  • 25 ampules of API AUX Medium
  • 25 result sheets
  • 1 package insert

Technical specifications

  • Strips consisting of 20 microtubes containing dehydrated substrates.
  • API AUX medium: 7 ml (to be reconstituted with demineralised water to make 1 L) composed of :
    • 2 g fo ammonium sulfate
    • 1.5 g agar
    • 10.5 ml vitamin solution
    • 10 ml trace elements
    • 6.24 g monosodium phosphate
    • 1.5 g potassium chloride
  • Oxidase test should be done separately.
  • The microtubes are inoculated with baterial suspension. The colours changes occur during incubation, due to metabolism, spontaneously or by addition of reagents..

Packaging & Labelling

Kit of 25 tests.

To be Ordered Separately

  • API NaCl 0.85% medium, 5 ml
  • Mineral oil
  • Oxidase
  • McFarland standard No. 0.5
  • Reagents: James, NIT 1 + NIT 2, Zn
  • Pipettes or PSIpettes
  • Ampule rack and protector
  • APIWEB software

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.
  • Do not use after expiry date.
  • Shelf life: 11 months.
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life.

(Cf Introduction: Thermosensitive products)

Waste management

After use, sterilise the cultures and all contaminated material. Contact your watsan referent for proper disposal.

MSF requirements

Reserved to bacteriology programmes

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