FDA.reportPublic FDA data

SoftGenePortal

Primary DI
00810142373791
Brand
SoftGenePortal
Company
SCC SOFT COMPUTER
Model
4.2.0.15
Published
2026-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00810142373791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810142373791008101423737918101423737910810142373791

GMDN Terms#

Term, Definition table
TermDefinition
Clinical decision management support softwareAn application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, guidelines links) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app.

Regulatory Flags#

DUNS number
131311409
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810142374279SoftBiobank1.0.1.142026-07-07
00810142373814SoftTotalQC5.0.0.122026-07-03
00810142373869SoftBiochemistry4.2.0.222026-06-10
00810142373876SoftCytogenetics4.2.0.222026-06-10
00810142373883SoftPathDx4.2.0.222026-06-10
00810142373890SoftFlowCytometry4.2.0.222026-06-10
00810142373906SoftHLA4.2.0.222026-06-10
00810142373920SoftMolecular4.2.0.222026-06-10
00810142373937SoftGenomics4.2.0.222026-06-10
00810142373944SoftTrack4.2.0.222026-06-10
00810142373012SoftPath4.4.7.42026-05-29
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
00810142374033SoftGenomics4.3.0.22026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374279SoftBiobankSCC SOFT COMPUTERJQP2026-07-07
00810142373814SoftTotalQCSCC SOFT COMPUTERJQP2026-07-03
00810142373869SoftBiochemistrySCC SOFT COMPUTERJQP2026-06-10
00810142373876SoftCytogeneticsSCC SOFT COMPUTERJQP2026-06-10
00810142373883SoftPathDxSCC SOFT COMPUTERJQP2026-06-10
00810142373890SoftFlowCytometrySCC SOFT COMPUTERJQP2026-06-10
00810142373906SoftHLASCC SOFT COMPUTERJQP2026-06-10
00810142373920SoftMolecularSCC SOFT COMPUTERJQP2026-06-10
00810142373937SoftGenomicsSCC SOFT COMPUTERJQP2026-06-10
00810142373944SoftTrackSCC SOFT COMPUTERJQP2026-06-10
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