LOWENSTEIN-JENSEN, dehydrated, 500g

STD SBCMAGARLWJ

Valid Article

Former Code(s): SLASLOJE5B-
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.
W0104010101 - Dehydrated culture media (dcm)
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.
The order of this product needs to be justified and is only acceptable under certain conditions.
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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LOWENSTEIN-JENSEN

Reserved for TB culture programmes.

Definition

Mixture of components used to prepare Lowenstein-Jensen egg-based medium. The prepared culture medium is used for the cultivation of Mycobacteria from clinical specimen or culture.

Specifications

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Components

BD: Approximate Formula Per 600 mL

  • Asparagine................................................................... 3.6 g
  • Monopotassium Phosphate.......................................... 2.4 g
  • Magnesium Sulfate..................................................... 0.24 g
  • Magnesium Citrate....................................................... 0.6 g
  • Potato Flour................................................................ 30.0 g
  • Malachite Green........................................................... 0.4 g

Liofilchem: Approximate Formula Per 600 mL

  • Magnesium Sulfate..................................................... 0.24 g
  • Asparagine................................................................... 3.6 g
  • Monopotassium Phosphate.......................................... 2.4 g
  • Magnesium Citrate....................................................... 0.6 g
  • Potato Flour................................................................ 30.0 g
  • Malachite Green........................................................... 0.4 g

Technical specifications

  • Soluble in water

BD :

  • dehydrated appearance: medium to dark green-blue, free flowing, homogeneoous
  • Prepared appearance: opalescent, viscous, dark blue green.

​Liofilchem:

  • dehydrated appearance: medium to dark green-blue, free flowing, homogeneoous
  • Prepared appearance: opaque, smooth slant, pale green

Instructions for use

Dissolve the powder by heating in distilled water and glycerol, and autoclave. To complete the medium, add filtered eggs using sterile procedure.

Perform Quality Control of the medium for each batch of tubes prepared.

Storage

  • Store the reagent between 10 and 30°C, in a closed container, protected from heat and humidity
  • Keep away from oxidizing substances
  • Tubes containing Lowenstein-Jensen medium are to be stored at refrigerator temperature (between +2ºC and +8ºC) and used within 4 weeks
  • Discard tubes showing change of colour of the medium during storage
  • Shelf life: BD - 6 years and Liofilchem - 4 years

(Cf Introduction: Thermosensitive products)

Waste management

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

  • Ocular irritation, category 2, H319
  • Toxic for reproduction, category 2, H361
  • Chronic hazard for aquatic environment, category 3, H412

(info from BD - check Liofilchem SDS in case you are using Liofilchem reagent)

Image Image

Signal Word

Warning

H319Causes serious eye irritation
H361Suspected of damaging fertility or the unborn child (route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
H412Harmful to aquatic life with long lasting effects
P405Store locked up.
P201Obtain special instructions before use.
P202Do not handle until all safety precautions have been read and understood.
P264Wash … thoroughly after handling
P273Avoid release to the environment
P280Wear protective gloves/protective clothing/eye protection/face protection
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P308 + P313IF exposed or concerned: Get medical advice/attention.
P337 + P313If eye irritation persists: get medical advice/attention
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

MSF requirements

Reserved for TB culture programmes.

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