HYDROFLEX 30087531

GUDID 09120052070446

Tecan Austria GmbH

Microplate washer IVD, automated

• Primary Device ID: 09120052070446
• NIH Device Record Key: 9e058373-595d-4c33-93dd-d29d76215121
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYDROFLEX
• Version Model Number: 09120052070446
• Catalog Number: 30087531
• Company DUNS: 301237509
• Company Name: Tecan Austria GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com
• Phone: +18003525128
• Email: helpdesk-us@tecan.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120052070446 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical 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: 2020-09-25
• Device Publish Date: 2020-09-17

Devices Manufactured by Tecan Austria GmbH

• 09120052071504 - USB-STICK MAGELLAN V 7.5: 2023-07-17 This media contains V 7.5 of the following registered Medical Devices: (DI)09120052070996 (SOFTWARE MAGELLAN V 7.X), (DI)0912005
• 09120052071184 - SUNRISE: 2023-07-14 microplate reader
• 09120052071191 - SUNRISE-RC/ST EVOLYZER: 2023-07-14 microplate reader - intended to be integrated in robotic solutions
• 09120052071207 - SUNRISE-RC/TW EVOLYZER: 2023-07-14 microplate reader - intended to be integrated in robotic solutions
• 09120052071214 - SUNRISE-RC/6F EVOLYZER: 2023-07-14 microplate reader - intended to be integrated in robotic solutions
• 09120052071344 - USB-STICK MAGELLAN PRO V7.5: 2023-03-06 This Media contains V7.5 of the following registered Medical Devices: (DI)09120052070880 SOFTWARE MAGELLAN PRO V7.x, (DI)0912005
• 09120052071351 - USB-STICK MAGELLAN PRO V7.4: 2022-08-25 This media contains V 7.4 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)091
• 09120052071146 - Infinite F50 Plus: 2022-06-03 The Infinite F50 Plus is an absorbance microplate reader for ELISA. It includes Magellan™ reader control and data analysis sof