Selectra

GUDID 03661540600418

ELITechGroup B.V.

Multiple clinical chemistry analyser IVD, laboratory, semi-automated

• Primary Device ID: 03661540600418
• NIH Device Record Key: eaf68443-edb8-4b1e-8575-c72e64c9f867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Selectra
• Version Model Number: ProS
• Company DUNS: 415733737
• Company Name: ELITechGroup B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540600418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102647

FDA Product Code

• CEM: Electrode, Ion Specific, Potassium

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-11-18

On-Brand Devices [Selectra]

• 03661540600418: ProS
• 03661540600401: ProM
• 03661540600395: ProM