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(API system) ZYM B reagent (NH,STAPH,STREP), kit [BMX-70493]

https://unicat.msf.org/cat/product/50420
STD SBIDAPISZYMB

Valid Article

Former Code(s): SLASZBE0535 SLASMISC241 SLASZBD0241
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.
UN1992
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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ZYM B, API reagent (Staph, NH, Coryne, Strep)

Definition

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

Specifications

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Components

R1: Methanol and Dimethylsulfoxide (DMSO)

R2: Fast Blue BB

Technical specifications

R1: Liquid colourless or nearly colourless.

R2: Off-white powder.

After reconstitution: Yellow to amber.

Packaging & Labelling

Kit composed of 2 x 5 ml of R1 and 2 x 0,007 g of R2.

Transport Dangerous Goods

R1:

  • UN1992
  • Class: 3 (6.1)
  • Packing group: III
  • Proper shipping name: Flammable liquid, toxic, n.s.o. (Méthanol Solution)

Instructions for use

  • Follow the instructions of the package insert.
  • Allow the reagent to come to room temperature before use.
  • Make sure that the reagent is put back in the fridge immediately after use.
  • ZYM B reagent should be destroyed as soon as it turn a shade of orange.

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 8°C.
  • Store in the dark.
  • Sensitive to traces of water, air and light.
  • To be used within 2 weeks after reconstitution.
  • 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.

Substance with hazardous characteristics. Presence of substance with potenital carcinogenic properties (H350). 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

R1:

  • Flammable liquids, Category 3, H226
  • Acute toxicity, oral, Category 4, H302
  • Acute toxicity, dermal, Category 3, H311
  • Acute toxicity, inhalation, Category 3, H331
  • Specific target organ toxicity - single exposure, Category 1, H370
Image Image Image

Signal Word

Danger

H226Flammable liquid and vapour.
H302Harmful if swallowed
H311Toxic in contact with skin.
H331Toxic if inhaled.
H370Causes damage to organs (or state all organs affected, if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
P210Keep away from heat/sparks/open flames/hot surfaces. – No smoking.
P280Wear protective gloves/protective clothing/eye protection/face protection
P301 + P312IF SWALLOWED: call a POISON CENTER or doctor/physician if you feel
P302 + P352IF ON SKIN: wash with plenty of soap and water
P304 + P340IF INHALED: Remove to fresh air and keep at rest in a position comfortable for breathing.

Signal Word

Warning

Image Image
H302Harmful if swallowed
H351Suspected of causing cancer (state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard).
P280Wear protective gloves/protective clothing/eye protection/face protection
P301 + P312IF SWALLOWED: call a POISON CENTER or doctor/physician if you feel
P308 + P313IF exposed or concerned: Get medical advice/attention.

MSF requirements

Reserved for bacteriology programmes.

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