FDA.reportPublic FDA data

MAGELLAN

Primary DI
09120052071009
Brand
MAGELLAN
Company
Tecan Austria GmbH
Model
MAGELLAN TRACKER V7.X
Catalog number
30183890
Device description
Reader control and data reduction software for Tecan Microplate Reader.
Published
2020-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQPCalculator/Data Processing Module, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120052071627PackageGS12In Commercial Distribution
09120052071641PackageGS15In Commercial Distribution
09120052071665PackageGS11In Commercial Distribution
09120052071009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120052071627091200520716279120052071627
09120052071641091200520716419120052071641
09120052071665091200520716659120052071665
09120052071009091200520710099120052071009

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDA software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlled device function and/or data processing, display, or communication (e.g., image conversion, incubation control).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18003525128helpdesk-us@tecan.com

Regulatory Flags#

DUNS number
301237509
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120052070880MAGELLAN PROMAGELLAN PRO V 7.X2020-01-07
09120052070910MAGELLAN PROMAGELLAN PRO TRACKER V 7.X2020-01-07
09120052070996MAGELLANMAGELLAN V7.X301838892020-12-01
09120052071320USB-STICK MAGELLAN PRO V7.530219868 00302198682023-02-26
09120052071238USB-STICK MAGELLAN V 7.5 SUNRISE+F5030204301 00302043012022-05-26
09120052071504USB-STICK MAGELLAN V 7.530231095 00302310952023-07-07
09120052071184SUNRISE30087502 02300875022023-07-06
09120052071191SUNRISE-RC/ST EVOLYZER30087504 02300875042023-07-06
09120052071207SUNRISE-RC/TW EVOLYZER30087505 02300875052023-07-06
09120052071214SUNRISE-RC/6F EVOLYZER30087506 02300875062023-07-06
09120052071344USB-STICK MAGELLAN PRO V7.530219868 00302198682023-02-26
09120052071351USB-STICK MAGELLAN PRO V7.430220141 00 302201412022-08-17
09120052071146Infinite F50 Plus30183570 00301835702022-05-26
09120052071160Hydroflex Plus30190374 00301903742022-05-26
09120052070521INFINITE 200 PRO30050303 01300503032021-06-22
09120052070453HYDROFLEX ELISA30087532 01300875322020-09-18
09120052070460HYDROFLEX EVOLYZER 8CH30087533 01300875332020-09-18
09120052070477HYDROFLEX EVOLYZER 16CH30087534 01300875342020-09-18
09120052070484HYDROFLEX FOR FREEDOM EVO30087535 01300875352020-09-18
09120052070385SUNRISE-RC/ST EVOLYZER30087504 01300875042020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142373012SoftPathSCC SOFT COMPUTERJQP2026-05-29
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28
00810142373715SoftBiochemistrySCC SOFT COMPUTERJQP2026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTERJQP2026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTERJQP2026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTERJQP2026-03-12
00810142373753SoftHLASCC SOFT COMPUTERJQP2026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTERJQP2026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTERJQP2026-03-12
00810142373784SoftTrackSCC SOFT COMPUTERJQP2026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTERJQP2026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTERJQP2026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-21
00810142373630SoftHLASCC SOFT COMPUTERJQP2026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTERJQP2026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTERJQP2026-02-21
00810142373661SoftTrackSCC SOFT COMPUTERJQP2026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-04