(Erba XL200) REAGENT KIT LIPASE XSYS0081
STD
ELAECCHC719
Valid Article
Last Updated on:
02/05/2024, 22:56:04
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
11
Shelf life = length of time a product can remain active and effective.
Short shelf life = shelf life = < 24 months
W01010123 - Lipase
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.
OC subscriptions: included in supply or field order tools (e.g. UniField)
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SC subscriptions: included in supply or field tools
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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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(Erba XL200) REAGENT KIT LIPASE XSYS0081
Definition
Reagent for quantitative in vitro determination of lipase (enzymatic, colorimetric method) in human serum and plasma using an Erba XL chemistry automate. .
Specifications
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Components
2 vials R1 (44 ml) + 2 vials R2 (11 ml)
Technical specifications
R1 Clear colourless liquid
R2: orange liquid
Packaging & Labelling
R1: 2 x 44 ml - R2: 2 x 11 ml
To be Ordered Separately
- Quality controls
- Calibrators
Instructions for use
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Storage
- The unopened reagents are stable till the expiry date stated on the bottle and kit label when stored at 2–8°C.
- Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
- Stability after first opening is 90 days at 2-8°C.
- On board stability: minimum 30 days if refrigerated (2–10°C) and not contaminated.
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
R2: Eye Damage 1, H318
Signal Word
R2: Danger
| H318 | Causes serious eye damage. |
| P280 | Wear protective gloves/protective clothing/eye protection/face protection |
| P305 + P351 + P338 | IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing |
MSF requirements
Use with the Erba XL200
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