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(API System) STAPH STRIP, Staphylococci [BMX-20500]

https://unicat.msf.org/cat/product/50432
STD SBIDAPISSTAPH

Valid Article

Former Code(s): SLASZBE0461 SLASMISC101 SLASZBD0101
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 STAPH STRIPS, Staphylococci

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 Staph is a standardized system for the identification of the genera Staphylococcus, Micrococcus and Kocuria, which uses miniaturized biochemical tests and a specially adapted database.

Inoculation and reading are done manually, and identification is done with the software.

Specifications

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Components

Kit of 25 tests:

  • 25 API Staph strips
  • 25 incubation boxes
  • 25 ampules of API Staph Medium (6 ml)
  • 25 result sheets
  • 1 package insert

Technical specifications

Strips consisting of 20 microtubes containing dehydrated substrates.

The colours changes occur during incubation, due to metabolism, spontaneously or by addition of reagents.

Packaging & Labelling

Kit of 25 strips.

To be Ordered Separately

  • Mineral oil
  • McFarland Standard, No. 0.5 on the scale.
  • VP 1 + VP 2
  • NIT 1 + NIT 2
  • ZYM A
  • ZYM B
  • Pipettes or PSIpettes
  • Ampule rack
  • Ampule protector
  • DENSIMAT (optional)
  • General microbiology laboratory equipment
  • ATB™ NEW or APIWEB™ software for identification

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, sterilize the cultures and all contaminated material. Contact your watsan referent for advice on proper disposal.

MSF requirements

Reserved to bacteriology programmes.

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