USB-STICK MAGELLAN 7.3 SP2 30182624

GUDID 09120052071023

This media contains the following registered Medical Devices: (DI) 09120052070996 MAGELLAN V7.X (DI) 09120052071009 MAGELLAN TRACKER V7.X

Tecan Austria GmbH

Laboratory instrument/analyser application software IVD
Primary Device ID09120052071023
NIH Device Record Key74f962ec-e168-4eac-9f25-d43bfc90cbf7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUSB-STICK MAGELLAN 7.3 SP2
Version Model Number30182624 00
Catalog Number30182624
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
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com
Phone+18003525128
Emailhelpdesk-us@tecan.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109120052071023 [Primary]
GS109120052071030 [Package]
Package: Carton box [1 Units]
In Commercial Distribution
GS109120052071047 [Package]
Package: Carton box [1 Units]
In Commercial Distribution
GS109120052071054 [Package]
Package: Carton box [1 Units]
In Commercial Distribution
GS109120052071061 [Package]
Package: Carton box [1 Units]
In Commercial Distribution
GS109120052071078 [Package]
Package: Carton box [1 Units]
In Commercial Distribution
GS109120052071085 [Package]
Package: Carton box [1 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 Date2020-12-09
Device Publish Date2020-12-01

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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