Indiko 98630000

GUDID 06438153001157

Clinical Chemistry Analyzer

Thermo Fisher Scientific Oy

Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory

• Primary Device ID: 06438153001157
• NIH Device Record Key: 3e76276d-9416-4770-920a-ee356662daa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Indiko
• Version Model Number: 863
• Catalog Number: 98630000
• Company DUNS: 540096708
• Company Name: Thermo Fisher Scientific Oy
• 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	06438153001157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110035

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-02
• Device Publish Date: 2023-07-25

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• 06438153000259 - Conveyor 2400, TCA: 2023-08-03 Conveyor 2400, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate t
• 06438153000266 - L-Turn, TCA: 2023-08-03 L-Turn, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the hand
• 06438153000297 - Conveyor 900, TCA: 2023-08-03 Conveyor 900, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate th