BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KleeYa®

    DI: 04260678680003 · Model: Fully automated CLIA analyzer · STRATEC SE
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    KleeYa®
    Primary DI
    04260678680003
    Version / Model
    Fully automated CLIA analyzer
    Catalog Number
    10108093
    Company Name
    STRATEC SE
    Labeler DUNS
    340361455
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-12
    Public Version
    1
    Public Version Date
    2025-11-20
    Public Version Status
    New
    Public Device Record Key
    5a022d37-1a05-4e61-b75e-18083c7dc393

    Device Description

    The KleeYa® System is a chemiluminescence platform intended for fully automated processing of dedicated immunoassays. This comprises sample processing (sample pre-dilutions, sample and reagent dispensing, incubations, wash processes) as well as quantitative determination of analytes, and evaluation of these measurements. Individual assays are carried out in specific disposable cuvettes. Specimen range is assay dependent and covers serum-like and aqueous-like liquids. Tested for aqueous-like: DI water with CLSI quality, tested for serum-like: 50 mM TRIS, 154 mM NaCl, 4% (w/w) BSA, 20% (v/v) Glycerin, 0.1% Proclin 300. The instrument is controlled via the PC software, allowing the user to control assay processing in an intuitive way and allows simple and quick operation of daily routine jobs. The KleeYa® System is designed for continuous loading and works on a sample-bysample basis. It is intended to be operated by professional, trained users in a laboratory environment. The device must be validated in the specific application in accordance with relevant regulatory requirements, laboratory practice and state-of-the-art, before putting into service and after implementation of changes. For in vitro diagnostics, use of assay kits or kit components on the KleeYa® System is only permitted after appropriate validation. The use and disposal of hazardous substances and potentially infectious material on the KleeYa® System should be the responsibility of the user in accordance with local regulations.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    GMDN Terms

    Code Name
    56701 Chemiluminescent immunoassay analyser IVD

    Identifiers

    Type ID
    Primary 04260678680003

    Customer Contacts

    Phone
    +490708279169300
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Operating Humidity: 20 - 80 % non-condensing
    Type
    Special Storage Condition, Specify
    Special Conditions
    Environmental condition: The system is made for indoor use only
    Type
    Special Storage Condition, Specify
    Special Conditions
    Operating Temperature: 18°C to 30°C (64.4°F to 86°F)
    Type
    Special Storage Condition, Specify
    Special Conditions
    Storage Temperature: 5°C to 40°C (41°F to 104°F)
    Type
    Special Storage Condition, Specify
    Special Conditions
    Transport Temperature: -20°C to 60°C (-4°F to 140°F)
    Type
    Special Storage Condition, Specify
    Special Conditions
    Storage Humidity: 10 - 85 % non-condensing
    Type
    Special Storage Condition, Specify
    Special Conditions
    Transport Humidity: 10 - 90 % non-condensing
    Type
    Special Storage Condition, Specify
    Special Conditions
    Pollution degree: 2
    Type
    Special Storage Condition, Specify
    Special Conditions
    Overvoltage category: II
    Type
    Special Storage Condition, Specify
    Special Conditions
    Altitude: Up to 2000 m (6562 ft) above mean sea level
    Type
    Special Storage Condition, Specify
    Special Conditions
    Dust: No excessive dust
    Type
    Special Storage Condition, Specify
    Special Conditions
    Limit class: Class A (For industrial use. Domestic use restricted)
    Type
    Special Storage Condition, Specify
    Special Conditions
    Sunlight: No direct sunlight. May mislead optical sensors and affect performance