FDA.reportPublic FDA data

SoftGenomics

Primary DI
00810142374033
Brand
SoftGenomics
Company
SCC SOFT COMPUTER
Model
4.3.0.2
Published
2026-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810142374033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810142374033008101423740338101423740330810142374033

GMDN Terms#

Term, Definition table
TermDefinition
Clinical laboratory information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks.

Regulatory Flags#

DUNS number
131311409
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810142374064SoftBiobank1.0.1.132026-05-05
00810142373807SoftBank25.6.3.12026-04-29
00810142373975SoftBiochemistry4.3.0.22026-04-16
00810142373982SoftCytogenetics4.3.0.22026-04-16
00810142373999SoftPathDx4.3.0.22026-04-16
00810142374002SoftFlowCytometry4.3.0.22026-04-16
00810142374019SoftHLA4.3.0.22026-04-16
00810142374026SoftMolecular4.3.0.22026-04-16
00810142374040SoftTrack4.3.0.22026-04-16
00810142373586SoftTotalQC1.0.11.12026-03-28
00810142373715SoftBiochemistry4.3.0.12026-03-12
00810142373722SoftCytogenetics4.3.0.12026-03-12
00810142373739SoftPathDx4.3.0.12026-03-12
00810142373746SoftFlowCytometry4.3.0.12026-03-12
00810142373753SoftHLA4.3.0.12026-03-12
00810142373760SoftMolecular4.3.0.12026-03-12
00810142373777SoftGenomics4.3.0.12026-03-12
00810142373784SoftTrack4.3.0.12026-03-12
00810142373340SoftTotalQC5.0.0.112026-03-11
00810142373593SoftBiochemistry4.2.0.212026-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00810142373524SoftPathDxSCC SOFT COMPUTERJQP2026-02-04
00810142373531SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-04