USB-STICK MAGELLAN V 7.5 30231095

GUDID 09120052071504

This media contains V 7.5 of the following registered Medical Devices: (DI)09120052070996 (SOFTWARE MAGELLAN V 7.X), (DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)

Tecan Austria GmbH

Laboratory instrument/analyser application software IVD
Primary Device ID09120052071504
NIH Device Record Keyab84a6b7-d48a-4151-8cdf-388a7868bcb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameUSB-STICK MAGELLAN V 7.5
Version Model Number30231095 00
Catalog Number30231095
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109120052071504 [Primary]
GS109120052071511 [Package]
Package: Plastic Box [2 Units]
In Commercial Distribution
GS109120052071528 [Package]
Package: Plastic Box [2 Units]
In Commercial Distribution
GS109120052071542 [Package]
Package: Plastic Box [5 Units]
In Commercial Distribution
GS109120052071559 [Package]
Package: Plastic Box [1 Units]
In Commercial Distribution
GS109120052071566 [Package]
Package: Plastic Box [1 Units]
In Commercial Distribution
GS109912005207135 [Package]
Package: Plastic Box [2 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 Date2023-07-17
Device Publish Date2023-07-07

Devices Manufactured by Tecan Austria GmbH

09120052071504 - USB-STICK MAGELLAN V 7.52023-07-17This media contains V 7.5 of the following registered Medical Devices: (DI)09120052070996 (SOFTWARE MAGELLAN V 7.X), (DI)09120052071009 (SOFTWARE MAGELLAN TRACKER V 7.X)
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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