FDA.reportPublic FDA data

USB-STICK MAGELLAN PRO V7.5

Primary DI
09120052071320
Brand
USB-STICK MAGELLAN PRO V7.5
Company
Tecan Austria GmbH
Model
30219868 00
Catalog number
30219868
Device description
This Media contains V7.5 of the following registered Medical Devices: (DI)09120052070880 SOFTWARE MAGELLAN PRO V7.x, (DI)09120052070910 SOFTWARE MAGELLAN PRO TRACKER V7.x
Published
2023-02-26
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
09120052071337PackageGS12Not in Commercial Distribution
09120052071344PackageGS12Not in Commercial Distribution
09120052071474PackageGS12In Commercial Distribution
09120052071481PackageGS12In Commercial Distribution
09120052071573PackageGS11In Commercial Distribution
09120052071320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120052071337091200520713379120052071337
09120052071344091200520713449120052071344
09120052071474091200520714749120052071474
09120052071481091200520714819120052071481
09120052071573091200520715739120052071573
09120052071320091200520713209120052071320

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

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
09120052071009MAGELLANMAGELLAN TRACKER V7.X301838902020-12-01
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