PROFI BLOT T48 30087538

GUDID 09120052070514

Tecan Austria GmbH

Blot processor IVD
Primary Device ID09120052070514
NIH Device Record Keyc2f0ecc8-88aa-4284-9834-5c3acd42f65e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROFI BLOT T48
Version Model Number09120052070514
Catalog Number30087538
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

Device Identifiers

Device Issuing AgencyDevice ID
GS109120052070514 [Primary]

FDA Product Code

KPASlide Stainer, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

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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