INFINITE 200 PRO 30050303

GUDID 09120052070521

microplate reader

Tecan Austria GmbH

Microplate reader IVD, automated
Primary Device ID09120052070521
NIH Device Record Key31ff1058-59e1-4204-a2a2-3ea449944021
Commercial Distribution StatusIn Commercial Distribution
Brand NameINFINITE 200 PRO
Version Model Number30050303 01
Catalog Number30050303
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
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
GS109120052070521 [Primary]

FDA Product Code

JJQColorimeter, Photometer, Spectrophotometer 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 Date2021-06-30
Device Publish Date2021-06-22

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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