(Erba XL200) REAGENT PANCREAS AMYLASE BLT00067
STD
ELAECCHC703
Valid Article
HS Code:
901890
Last Updated on:
30/06/2025, 00:42:56
W01010108 - Amylase isoenzymes
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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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 PANCREATIC AMYLASE BLT00067
Definition
Reagent for quantitative in vitro determination of pancreatic amylase in human serum, plasma and urine using the Erba XL clinical chemistry automate.
Specifications
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Components
R1:
- Good's buffer, pH 7.10 125 mmol/l
- CaCl 62.5 mmol/l
- MagCl2 12.5 mmol/l
- α-glukosidase > 42 µkat/l
- Monoclonal antibodies > 31 mg/l
R2:
- Good's buffer, pH 7.10 500 mmol/l
- 4,6-Ethyliden-4-nitrophenyl-maltoheptaoside 8 mmol/l
Technical specifications
- Reagents are ready to use
- R1 : Colourless liquid
- R2: Yellow liquid
- Samples: serum, plasma (heparin, EDTA) or urine
Packaging & Labelling
R1: 4 x 20 ml - R2: 1 x 20 ml
Transport Dangerous Goods
Transport not regulated
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.
- After opening, stable until expiry date if refrigerated (2–8°C) if stored at appropriate conditions, closed carefully and not contaminated.
Waste management
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
Not classified as hazardous
MSF requirements
Use with the Erba XL200
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