(Erba XL200) REAGENT KIT AST/GOT XSYS0016

STD ELAECCHC735

Valid Article


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
W01010110 - Aspartate amino-transferase
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.
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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(Erba XL200) REAGENT KIT AST/GOT, XSYS0016

Definition

Reagent for quantitative in vitro determination of AST/GOT (Aspartate Aminotransferase) in human serum and plasma using the Erba XL clinical chemistry automate.

Specifications

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Components

R1:

  • Tris buffer, pH 7.8 110 mmol/l
  • L-aspartic acid 340 mmol/l
  • LDH >= 4000 U/l
  • MDH >= 750 U/l

R2

  • CAPSO 20 mmol/l
  • 2-oxoglutarate 85 mmol/l
  • NADH 1.05 mmol/l

Hazardous substance: aspartic acid, Tris(hydroxymethyl)aminomethane, sodium hydroxide

Technical specifications

  • Ready to use
  • R1 and R2: Clear colourless liquids
  • 1500 tests
  • Sample: non haemolysed serum or plasma (heparin, EDTA)

Packaging & Labelling

R1: 6 x 44 ml - R2: 6 x 11 ml

Transport Dangerous Goods

Transport not regulated

To be Ordered Separately

  • Quality controls
  • Calibrators

Instructions for use

Storage

  • The unopened reagents are stable till the expiry date stated on the bottle and kit label when stored at 2–8°C.
  • On board stability: minimum 30 days if refrigerated (2–10°C) and not contaminated.
  • Shelf life : 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life

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

R1:

  • Skin irrit. 2, H315
  • Eye Irrit. 2, H319

R2: not classified as hazardous

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Signal Word

Warning

H315Causes skin irritation
H319Causes serious eye irritation
P280Wear protective gloves/protective clothing/eye protection/face protection
P302 + P352IF ON SKIN: wash with plenty of soap and water
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

MSF requirements

Use with the Erba XL200

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