(APISyst) NIT1-NIT2 reagents (10S,20E,20NE,STAPH)[BMX-70442]

STD SBIDAPISNIT

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Former Code(s): SLASZBD0105
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
W0104080299 - Manual identification - 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.
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).
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)
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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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NIT1 & NIT2, API reagents (20E, 10S, 20NE, Staph, Coryne)

Definition

NIT1 and NIT 2 reagents are 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) or staphylococcus (API STAPH) (and other strips: Coryne and 10S).

Synonym

NIT 1: sulfanic acid

NIT 2: NN dimethyl-alpha-naphtylamine

Specifications

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Components

NIT 1: Sulfanilic acid, acetic acid and H2O

NIT 2: N,N-dimethyl-1-naphtylamine, acetic acid and H2O

Technical specifications

NIT 1 and NIT 2: clear liquids, nearly colourless

Packaging & Labelling

Kit composed of 2 reagents: 2 x NIT 1 and 2 x NIT 2

4 x 5 ml

Transport Dangerous Goods

NIT 1 and NIT 2:

  • UN 2790
  • Class: 8
  • Packing group: III
  • Proper shipping name: Acetic acid solution, with more than 10% and less than 50% acid, by mass

Instructions for use

  • Follow the instructions of the package insert
  • Allow the reagents to come to room temperature before use
  • Make sure that the reagents are put back in the refrigerator immediately after use

Please consult the “Bacteriology laboratory procedures and resources” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resourceshttps://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 NIT 2 between 2°C and 8°C and NIT 1 beteen 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: 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. 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

NIT 1 and NIT 2:

  • Skin corrosion/irritation, Category 1, H314
  • Serious eye damage/eye irritation, Category 1
  • Hazardous to the aquatic environment, long-term aquatic hazard, Category 3
Image

Signal Word

Danger

H314Causes severe skin burns and eye damage.
P264Wash … thoroughly after handling
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
P337 + P313If eye irritation persists: get medical advice/attention

Signal Word

Danger

Image
H314Causes severe skin burns and eye damage.
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
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 bacteriology programmes

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