HYDROFLEX ELISA 30087532

GUDID 09120052070453

Microplate washer IVD, automated

Primary Device ID	09120052070453
NIH Device Record Key	e93a049c-248d-45cb-9d08-3e44521147af
Commercial Distribution Status	In Commercial Distribution
Brand Name	HYDROFLEX ELISA
Version Model Number	30087532 01
Catalog Number	30087532
Company DUNS	301237509
Company Name	Tecan Austria GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	09120052070453 [Primary]

LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Steralize Prior To Use	false
Device Is Sterile	false

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09120052071191 - SUNRISE-RC/ST EVOLYZER	2023-07-14 microplate reader - intended to be integrated in robotic solutions
09120052071207 - SUNRISE-RC/TW EVOLYZER	2023-07-14 microplate reader - intended to be integrated in robotic solutions
09120052071214 - SUNRISE-RC/6F EVOLYZER	2023-07-14 microplate reader - intended to be integrated in robotic solutions
09120052071344 - USB-STICK MAGELLAN PRO V7.5	2023-03-06 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 V7.4	2022-08-25 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 Plus	2022-06-03 The Infinite F50 Plus is an absorbance microplate reader for ELISA. It includes Magellan™ reader control and data analysis sof