Indiko 98630000

GUDID 06438153001157

Clinical Chemistry Analyzer

Thermo Fisher Scientific Oy

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

Devices Manufactured by Thermo Fisher Scientific Oy

• 06438153000129 - Entry, TCA: 2023-08-03 Entry, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the handl
• 06438153000143 - Exit, TCA: 2023-08-03 Exit, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the handli
• 06438153000211 - Conveyor 600, TCA: 2023-08-03 Conveyor 600, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate th
• 06438153000228 - Conveyor 1200, TCA: 2023-08-03 Conveyor 1200, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate t
• 06438153000235 - Conveyor 1500, TCA: 2023-08-03 Conveyor 1500, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate t
• 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