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(API System) JAMES reagent (NH,10S,20E,20NE),kit [BMX-70542]

https://unicat.msf.org/cat/product/45216
STD SBIDAPISJAMES

Valid Article

Former Code(s): SLASZBD0108
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.
12
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.
UN1789
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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JAMES, reagent for API (NH, 20E, 20NE, 10S)

Definition

James reagent is to be used with API strips, for the identification of enterobacteriae and other Gram negatif bacilli non fastidious (API 20 E), Gram negative bacilli, non-enterobacteriae and non fastidious (API 20 NE), Neisseria or Haemophilus (API NH-included in kit) (and other strip: 10S).

Specifications

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Components

R1: Hydrochloric acid 1N

R2: Compound J 2183 (confidential)

Technical specifications

R1: clear liquid, colourless or nearly colourless

R2: powder, solid, off-white before reconstitution and yellow after reconstitution

Packaging & Labelling

Kit composed of 2 reagents: R1 and R2

2 x 5 ml of R1 and 2 x 0.033 g of R2

Transport Dangerous Goods

R1:

  • UN 1789
  • Class: 8
  • Packing group: III
  • Proper shipping name: Hydrochloric acid

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 refrigerator immediately after use
  • Wrap the dropper-bottle in aluminium foil to protect it from light
  • The James reagent must be used only if it is pale yellow. If a pink color appears when the reagent is reconstituted with the solvent, wait until this pink color has completely disappeared before using it.

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 (R1 could be stored between 2 and 30°C)
  • Keep away from light
  • Do not use after the expiry date
  • After opening, to be used within 1 month
  • Shelf life: 12 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. 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:

  • Skin corrosion/irritation, Category 1, H314
  • Serious eye damage/ eye irritation, Category 1, H318
Image

Signal Word

Danger

H314Causes severe skin burns and eye damage.
H318Causes serious eye damage.
P260Do not breathe dust/fume/gas/mist/vapours/spray.
P264Wash … thoroughly after handling
P280Wear protective gloves/protective clothing/eye protection/face protection
P310Immediately call a POISON CENTER or doctor/physician.
P363Wash contaminated clothing before reuse.
P301 + P330 + P331IF SWALLOWED: rinse mouth. Do NOT induce vomiting
P303 + P361 + P353IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing.
P304 + P340IF INHALED: Remove to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

Signal Word

Warning

Image
H315Causes skin irritation
H319Causes serious eye irritation
H335May cause respiratory irritation
P260Do not breathe dust/fume/gas/mist/vapours/spray.
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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