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 ID09120052071269
NIH Device Record Key5b36f42f-c2a2-4ce4-9806-0e809ddb9479
Commercial Distribution StatusIn Commercial Distribution
Brand NameUSB-STICK MAGELLAN PRO V 7.5
Version Model Number30204301 00
Catalog Number30204301
Company DUNS301237509
Company NameTecan Austria GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109120052071238 [Primary]
GS109120052071269 [Package]
Contains: 09120052071238
Package: Carton Box. [2 Units]
In Commercial Distribution
GS109120052071276 [Package]
Contains: 09120052071238
Package: Carton Box. [2 Units]
In Commercial Distribution
GS109120052071283 [Package]
Contains: 09120052071238
Package: Carton Box. [5 Units]
In Commercial Distribution
GS109120052071290 [Package]
Contains: 09120052071238
Package: Carton Box. [5 Units]
In Commercial Distribution
GS109120052071306 [Package]
Contains: 09120052071238
Package: Carton Box. [1 Units]
In Commercial Distribution
GS109120052071313 [Package]
Contains: 09120052071238
Package: Carton Box. [1 Units]
In Commercial Distribution
GS109120052071412 [Package]
Contains: 09120052071238
Package: Plastic Box [2 Units]
In Commercial Distribution
GS109120052071429 [Package]
Contains: 09120052071238
Package: Plastic Box [2 Units]
In Commercial Distribution
GS109120052071436 [Package]
Contains: 09120052071238
Package: Plastic Box [5 Units]
In Commercial Distribution
GS109120052071443 [Package]
Contains: 09120052071238
Package: Plastic Box [5 Units]
In Commercial Distribution

FDA Product Code

JQPCalculator/Data Processing Module, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-03
Device Publish Date2022-05-26

Devices Manufactured by Tecan Austria GmbH

09120052071504 - USB-STICK MAGELLAN V 7.52023-07-17 This media contains V 7.5 of the following registered Medical Devices: (DI)09120052070996 (SOFTWARE MAGELLAN V 7.X), (DI)0912005
09120052071184 - SUNRISE2023-07-14 microplate reader
09120052071191 - SUNRISE-RC/ST EVOLYZER2023-07-14 microplate reader - intended to be integrated in robotic solutions
09120052071207 - SUNRISE-RC/TW EVOLYZER2023-07-14 microplate reader - intended to be integrated in robotic solutions
09120052071214 - SUNRISE-RC/6F EVOLYZER2023-07-14 microplate reader - intended to be integrated in robotic solutions
09120052071344 - USB-STICK MAGELLAN PRO V7.52023-03-06 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 V7.42022-08-25 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 Plus2022-06-03 The Infinite F50 Plus is an absorbance microplate reader for ELISA. It includes Magellan™ reader control and data analysis sof

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