(Erba XL200) REAGENT KIT ALKALINE PHOSPHATASE XSYS0002
STD
ELAECCHC732
Valid Article
Last Updated on:
07/05/2025, 22:07:02
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.
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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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SC subscriptions: included in supply or field tools
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(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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Components
R1:
- AMP buffer, pH 10.4 434 mmol/l
- Magnesium acetate 2.48 mmol/l
- Zinc sulfate 1.24 mmol/l
- HEDTA 2.48 mmol/l
R2:
- p-nitrophenyl phosphate 8.16 mmol/l
Technical specifications
- Ready to use
- R1: colorless liquid
- R2: yellow liquid
- 500 tests
- Sample: serum, plasma (heparin)
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
R1: not classified as hazardous
R2:
- Skin Irrit. 2, H315
- Eye Irrit. 2, H319
Signal Word
Warning
| H315 | Causes skin irritation |
| H319 | Causes serious eye irritation |
| P280 | Wear protective gloves/protective clothing/eye protection/face protection |
| P302 + P352 | IF ON SKIN: wash with plenty of soap and water |
| 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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