(Erba XL200) REAGENT KIT BILIRUBIN DIRECT XSYS0028
STD
ELAECCHC706
Valid Article
HS Code:
901890
Last Updated on:
06/05/2025, 22:03:00
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
W01010203 - Bilirubin
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 BILIRUBIN DIRECT XSYS0028
Definition
Reagent for quantitative in vitro determination of Bilirubin Direct (Walter and Gerard method) in human serum and plasma using an Erba XL chemistry automate.
Specifications
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Components
R1:
- Sulphanilic acid 28.87 mmol/l
- HCl 23 mmol/l
R2:
- Sodium nitrile 2.9 mmol/l
Technical specifications
- Reagents ready to use
- R1 and R2: Clear colourless liquids
- 1200 tests
- Sample: non heamolytic serum or plasma (heparin, EDTA)
Packaging & Labelling
R1: 6 x 44 ml - R2: 6 x 11 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.
- On board stability: stable minimum 30 days if refrigerated (2–10°C) and not contaminated.
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:
- Skin corrosion 1, H314
- Eye Damage 1, H318
R2: not considered as hazardous
Signal Word
Danger
H314 | Causes severe skin burns and eye damage. |
EUH208 | supplied by the manufacturer. Comply with the safety instructions. Contains (name of sensitising substance). May produce an allergic reaction. Contains (name of sensitising substance). May produce an allergic reaction. |
P260 | Do not breathe dust/fume/gas/mist/vapours/spray. |
P280 | Wear protective gloves/protective clothing/eye protection/face protection |
P301 + P330 + P331 | IF SWALLOWED: rinse mouth. Do NOT induce vomiting |
P303 + P361 + P353 | IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. |
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 |
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