(Erba XL200) REAGENT CREATININE KINASE XSYS0022
NST
ELAECCHC710
Valid Article
HS Code:
901890
Last Updated on:
08/05/2025, 22:02:02
12
Shelf life = length of time a product can remain active and effective.
Short shelf life = shelf life = < 24 months
W01010113 - Creatine kinase - 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 CREATININE KINASE XSYS0022
Definition
Reagent for quantitative in vitro determination of creatinine kinase (IFCC & DGKCH method) in human serum and plasma using an Erba XL chemistry automate.
Specifications
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Components
R1:
- Imidazole buffer, pH 6.1 125 mmol/l
- Glucose 25 mmol/l
- Magnesium acetate 12.5 mmol/l
- EDTA 2 mmol/l
- N-acetylcysteine 25 mmol/l
- NADP 2.4 mmol/l
- Hexokinase > 6.8 U/ml
R2:
- Imidazole buffer, pH 8.9 125 mmol/l
- ADP 15.2 mmol/l
- D-glukoso-6-phosphate-dehydrogenase > 8.8 U/ml
- Creatine phosphatase 250 mmol/l
- AMP 25 mmol/l
- Diadenosine pentaphosphate 103 µmol/l
Hazardous substance: imidazole
Technical specifications
- Ready to use
- R1 and R2: colourless liquids
- R1: rotten, sulfurous odour
- R2: odourless
- 500 tests
- Sample: non heamolysed serum or plasma (heparin, EDTA)
Packaging & Labelling
R1: 2 x 44 ml - R2: 2 x 11 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.
- On board stability: minimum 30 days if refrigerated (2–10°C) and not contaminated.
- Shelflife: 12 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
(R1 and R2) Repr. 1B, H360D
Signal Word
Danger
| H360D | May damage the unborn child |
| P201 | Obtain special instructions before use. |
| P280 | Wear protective gloves/protective clothing/eye protection/face protection |
| P308 + P313 | IF exposed or concerned: Get medical advice/attention. |
Signal Word
Danger
| H360D | May damage the unborn child |
| P201 | Obtain special instructions before use. |
| P280 | Wear protective gloves/protective clothing/eye protection/face protection |
| P308 + P313 | IF exposed or concerned: Get medical advice/attention. |
MSF requirements
Use with the Erba XL200
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