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(API System) ZYM A reagent (STAPH,STREP) [BMX-70494]

https://unicat.msf.org/cat/product/50419
STD SBIDAPISZYMA

Valid Article

Former Code(s): SLASZBE0534 SLASMISC109 SLASZBD0109
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
W0104080208 - Single tests (discs, strips, droppers...)
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.
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).
CT30
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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ZYM A, API reagent (Staph, Strep, Coryne)

Definition

ZYM A reagent is used with API strips Staph for the identification of Staphylococcus (and with other strips: Strep, Coryne).

Specifications

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Components

Tris-hydroxymethyl-aminomethane, Hydrochloric acid (37%), Sodium lauryl sulfate, H2O.

Technical specifications

Liquid, colourless or nearly colourless. Foamy after shaking.

Packaging & Labelling

Kit composed of 2 x 8 ml of ZYM A reagent.

Instructions for use

  • Follow the instructions of the package insert.
  • Allow the reagent to come to room temperature before use .
  • At 2°C-8°C, the ZYM A reagent may form a precipitate which does not affect any of the properties of the reagent and which disappears when the reagent reaches room temperature.
  • Make sure that the reagent is put back in the fridge immediately after use (if applicable)

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

  • Store between 2°C and 30°C.
  • Store in the dark.
  • To be used within one month after opening.
  • Do not use after expiry date.
  • Shelf life: 11 months.
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life.

Waste management

After use, sterilize the cultures and all contaminated material.

Substance with hazardous 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).

Classification EC Regulation N° 1272/2008

  • Hazardous to the aquatic environment, long-term hazard, Category 3, H412
Image

Signal Word

Warning

H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation
H412Harmful to aquatic life with long lasting effects
P280Wear protective gloves/protective clothing/eye protection/face protection
P302 + P352IF ON SKIN: wash with plenty of soap and water

MSF requirements

Reserved for bacteriology programmes.

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