(Erba XL200) REAGENT KIT CREATININE Jaffé XSYS0024
NST
ELAECCHC702
Valid Article
HS Code:
901890
Last Updated on:
27/06/2024, 22:01:12
W01010207 - Creatinine
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 KIT CREATININE XSYS0024
Definition
Reagent for quantitative in vitro determination of Creatinine using the Jaffé method in human serum, plasma and urine using the Erba XL200 automate.
Specifications
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Components
R1: 5 x 44 ml - R2: 5 x 11 ml
Technical specifications
- R1: Clear colourless liquid
- R2: clear yellow liquid
- 1250 tests
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: 12 days if refrigerated (2–10°C), not contaminated and if chimneys are used (provided with the kit).
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 1 contains 1.0 % sodium hydroxide
- Reagent 2 contains <0,6% picric acid, 0,05% copper sulphate pentahydrate and 0,03% sodium hydroxide
Classification EC Regulation N° 1272/2008
Reagent 1:
- 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
Note: Creatinine enzymatic reagents is preferred over Jaffé, reasons: 1) preferred by IFCC and 2) longer stability of the enzymatic reagents after opening
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