(Erba XL200) REAGENT CREATININE KINASE XSYS0022
NST
ELAECCHC710
Valid Article
HS Code:
901890
Last Updated on:
11/12/2024, 19:21:36
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.
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
(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
2 vials R1 (44 ml) + 2 vials R2 (11 ml)
Technical specifications
- R1 and R2: colourless and odourless liquids
- 500 tests
Packaging & Labelling
R1: 2 x 44 ml - R2: 2 x 11 ml
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.
- 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
MSF requirements
Use with the Erba XL200
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