(Erba XL200) REAGENT KIT ALKALINE PHOSPHATASE XSYS0002
STD
ELAECCHC732
Valid Article
Last Updated on:
07/11/2024, 18:34:10
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).
W01010105 - Alkaline phosphatase - total
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.
(Erba XL200) REAGENT KIT ALKALINE PHOSPHATASE, XSYS0002
Definition
Diagnostic reagent for quantitative in vitro determination of alkaline phosphatase or ALP in human serum and plasma.
Specifications
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Technical specifications
- R1: colorless liquid
- R2: yellow liquid
- 500 tests
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.
- On board stability: min. 12 days if refrigerated (2–10°C) and not contaminated and if chimneys are used.
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).
Reagent R2 also contains <0.7% KOH and is classified as irritant.
Classification EC Regulation N° 1272/2008
R2:
- Skin Irrit. 2, H315
- Eye Irrit. 2, H319
Signal Word
Warning
H315 | Causes skin irritation |
H319 | Causes serious eye irritation |
MSF requirements
Use with the Erba XL200
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