IDS i20

Basic Information

• Brand Name: IDS i20
• Primary DI: 05060169696693
• Version / Model: IS-910400
• Company Name: IMMUNODIAGNOSTIC SYSTEMS FRANCE
• Labeler DUNS: 381472984
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-20
• Public Version: 1
• Public Version Date: 2024-12-30
• Public Version Status: New
• Public Device Record Key: bf79d074-bea7-4e91-85c9-d3532356adb5

Device Description

Automated analyser for in-vitro diagnosis of clinical biology

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56724	Multichannel immunoassay analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple chemical and/or biological markers in a clinical specimen. The analyser typically includes sample processing, requires analyte specific test kits or reagents, and incorporates multiple channels using two or more immunological methods which may include chromatographic or electrochemical separation, together with enzyme, fluorescent, chemiluminescent, nephelometric, radiometric, electrometric and/or photometric detection systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060169696693	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.