← Back to catalogue

Magellan Pro

FDA UDI

Class I (US FDA UDI)

by Tecan Austria GmbH

Identity

Trade Name
MAGELLAN PRO FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
Reader control and data reduction software for Tecan Microplate Reader. FDA UDI
Model / Reference
MAGELLAN PRO V 7.X FDA UDI
Description
Reader control and data reduction software for Tecan Microplate Reader. FDA UDI

Identifiers

Primary DI / UDI-DI
09120052070880 FDA UDI
FDA Product Code
JQP FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

Magellan Pro by Tecan Austria GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Tecan Austria GmbH

Sources (1)

  • FDA UDI 7442692e-2e9a-41e7-8c64-282bccfe94f1 34 fields · synced May 30, 2026