USB-STICK MAGELLAN PRO V 7.5 30204301

GUDID 09120052071269

This media contains V 7.3 of the following registered Medical Devices: (DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X), (DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)

Tecan Austria GmbH

Laboratory instrument/analyser application software IVD

• Primary Device ID: 09120052071269
• NIH Device Record Key: 5b36f42f-c2a2-4ce4-9806-0e809ddb9479
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USB-STICK MAGELLAN PRO V 7.5
• Version Model Number: 30204301 00
• Catalog Number: 30204301
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120052071238 [Primary]
GS1	09120052071269 [Package]; Contains: 09120052071238; Package: Carton Box. [2 Units]; In Commercial Distribution
GS1	09120052071276 [Package]; Contains: 09120052071238; Package: Carton Box. [2 Units]; In Commercial Distribution
GS1	09120052071283 [Package]; Contains: 09120052071238; Package: Carton Box. [5 Units]; In Commercial Distribution
GS1	09120052071290 [Package]; Contains: 09120052071238; Package: Carton Box. [5 Units]; In Commercial Distribution
GS1	09120052071306 [Package]; Contains: 09120052071238; Package: Carton Box. [1 Units]; In Commercial Distribution
GS1	09120052071313 [Package]; Contains: 09120052071238; Package: Carton Box. [1 Units]; In Commercial Distribution
GS1	09120052071412 [Package]; Contains: 09120052071238; Package: Plastic Box [2 Units]; In Commercial Distribution
GS1	09120052071429 [Package]; Contains: 09120052071238; Package: Plastic Box [2 Units]; In Commercial Distribution
GS1	09120052071436 [Package]; Contains: 09120052071238; Package: Plastic Box [5 Units]; In Commercial Distribution
GS1	09120052071443 [Package]; Contains: 09120052071238; Package: Plastic Box [5 Units]; In Commercial Distribution

FDA Product Code

• JQP: Calculator/Data Processing Module, 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: 2022-06-03
• Device Publish Date: 2022-05-26

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