(Erba XL200) REAGENT ALPHA AMYLASE XSYS0003
NST
ELAECCHC717
Valid Article
HS Code:
901890
Last Updated on:
06/05/2025, 22:07:44
19
Shelf life = length of time a product can remain active and effective.
Short shelf life = shelf life = < 24 months
W01010107 - Amylase - 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.
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 ALPHA AMYLASE XSYS0003
Definition
Reagent for quantitative in vitro determination of alpha amylase in human serum, plasma and urine using an Erba XL chemistry automate.
Specifications
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Components
- MES buffer 50 mmol/l
- Calcium chloride 3.81 mmol/l
- Sodium chloride 300 mmol/l
- Potassium thiocyanate 450 mmol/l
- Sodium azide 13.85 mmol/l
- CNPG 0.91 mmol/l
Hazardous substance: potassium thiokyanate
Technical specifications
- Ready to use
- Clear colourless liquid
- Sample: serum, plasma (heparin, EDTA) or urine
Packaging & Labelling
5 x 22 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.
- After opening, stable minimum 30 days if refrigerated (2–10°C) and not contaminated.
- Shelflife: 19 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
Eye damage, 1, H318
Signal Word
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 |
| P337 + P313 | If eye irritation persists: get medical advice/attention |
MSF requirements
Use with the Erba XL200
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