(clinical chem. Piccolo) METLYTE 8 PANEL, 400-0023
STD
ELAECCHT404
Valid Article
Account code:
60200
HS Code:
901890
Last Updated on:
08/05/2024, 22:11:02
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
12
Shelf life = length of time a product can remain active and effective.
Short shelf life = shelf life = < 24 months
W01010404 - Multiple parameters (mix of all) - clin. chem lab r.
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.
(clinical chemistry Piccolo) METLYTE 8
Definition
The Piccolo MetLyte 8 panel, used with the Piccolo Xpress chemistry analyser, is a single cartridge in the form of a disk and provides in vitro quantitative determinations of 8 different clinical chemistry parameters.
Specifications
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Technical specifications
- Unit-use self-calibrating plastic reagent disc: Piccolo MetLyte 8
- 1 disc is aimed to perform the tests for 1 patient
- Parameters
- BUN: Blood Urea Nitrogen
- CK: Creatine kinase
- Cl-: Chloride
- CRE: Creatinine
- GLU: Glucose
- K+: Potassium
- Na+: Sodium
- tCO2: Total carbon dioxide
- Sample volume: 100 µl
- Sample type: serum, plasma, whole blood (collected with lithium heparin only)
- Test duration: approx. 12 minutes
Packaging & Labelling
Box of 10 discs, ref. 400-0023 (one Piccolo MetLyte 8 dics, ref. 400-1023)
To be Ordered Separately
- Controls: low and high (see related items)
Instructions for use
Follow instructions on package insert and/or operating manual.
Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.
https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx
For offline access, contact your laboratory advisor.
Precautions for Use
- Do not reuse a disk even if the operation was interrupted.
- Never use a disk that was dropped or cracked, as it may spread biohazardous material through the interior of the analyser, and it can affect the results.
Storage
- Keep refrigerated between 2 and 8°C, Protect from sunlight
- When taking out of the refrigerator, condensation can appear. The disks can stay 48 hours at ambient temperature.
- Do not freeze
- Shelf life: min 12 months
- Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
Signal Word
Warning
H302 | Harmful if swallowed |
H315 | Causes skin irritation |
H335 | May cause respiratory irritation |
EUH401 | To avoid risks to human health and the environment, comply with the instructions for use. |
P403 + P235 | Store in a well-ventilated place. Keep cool. |
P235 | Keep cool. |
P273 | Avoid release to the environment |
P308 + P313 | IF exposed or concerned: Get medical advice/attention. |
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