FDA.reportPublic FDA data

HERA

Primary DI
04250289512909
Brand
HERA
Company
Aesku.Diagnostics GmbH & Co. KG
Model
REF.HER-1000
Published
2023-07-20
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
04250289512909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289512909042502895129094250289512909

GMDN Terms#

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

Regulatory Flags#

DUNS number
341714388
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
04250289502849AESKULISA® ß2-Glyco-Check30-7215US30-7215US2017-02-28
04250289502894AESKULISA® ASCA-A30-7507US30-7507US2017-02-28
04250289502979AESKULISA® SS-A7107US7107US2017-02-28
04250289503006AESKULISA® Cenp-B7112US7112US2017-02-28
04250289504584AESKULISA® DGP-A30-7513US30-7513US2017-02-28
04250289500470AESKULISA® snRNP-C31052016-09-27
04250289500494AESKULISA® SS-A31072016-09-27
04250289500548AESKULISA® Cenp-B31122016-09-27
04250289500838AESKULISA® Cardiolipin-A32032016-09-27
04250289500852AESKULISA® ß2-Glyco-A32052016-09-27
04250289500951AESKULISA® ß2-Glyco-Check32152016-09-27
04250289501491AESKULISA® Glia-G35022016-09-27
04250289501521AESKULISA® ASCA-A35072016-09-27
04250289501538AESKULISA® ASCA-G35082016-09-27
04250289503051AESKULISA® Cardiolipin-A7203US7203US2017-02-28
04250289503624AESKULISA® DGP-A35132016-09-27
04250289500432AESKULISA® ANA-8Pro31012016-09-27
04250289500449AESKULISA® ENA-6S31022016-09-27
04250289500531AESKULISA® Scl-7031112016-09-27
04250289500555AESKULISA® Jo-131132016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374941SoftBiochemistrySCC SOFT COMPUTERJQP2026-10-16
00810142374958SoftCytogeneticsSCC SOFT COMPUTERJQP2026-10-16
00810142374965SoftPathDxSCC SOFT COMPUTERJQP2026-10-16
00810142374972SoftFlowCytometrySCC SOFT COMPUTERJQP2026-10-16
00810142374989SoftHLASCC SOFT COMPUTERJQP2026-10-16
00810142374996SoftMolecularSCC SOFT COMPUTERJQP2026-10-16
00810142375009SoftGenomicsSCC SOFT COMPUTERJQP2026-10-16
00810142375016SoftTrackSCC SOFT COMPUTERJQP2026-10-16
00810142374071SoftTotalQCSCC SOFT COMPUTERJQP2026-10-07
00810142373456SoftLabSCC SOFT COMPUTERJQP2026-09-29
00810142373463SoftMicSCC SOFT COMPUTERJQP2026-09-29
B236CATL202520Clinisys AtlasCliniSys, IncJQP2026-09-29
00380740225384AlinIQABBOTT SRLJQP2026-09-28
00810142374378SoftBiochemistrySCC SOFT COMPUTERJQP2026-08-26
00810142374385SoftCytogeneticsSCC SOFT COMPUTERJQP2026-08-26
00810142374392SoftPathDxSCC SOFT COMPUTERJQP2026-08-26
00810142374408SoftFlowCytometrySCC SOFT COMPUTERJQP2026-08-26
00810142374415SoftHLASCC SOFT COMPUTERJQP2026-08-26
00810142374422SoftMolecularSCC SOFT COMPUTERJQP2026-08-26
00810142374439SoftGenomicsSCC SOFT COMPUTERJQP2026-08-26
00810142374446SoftTrackSCC SOFT COMPUTERJQP2026-08-26
00810142374453SoftBiochemistrySCC SOFT COMPUTERJQP2026-07-14
00810142374460SoftCytogeneticsSCC SOFT COMPUTERJQP2026-07-14
00810142374477SoftPathDxSCC SOFT COMPUTERJQP2026-07-14
00810142374484SoftFlowCytometrySCC SOFT COMPUTERJQP2026-07-14
00810142374491SoftHLASCC SOFT COMPUTERJQP2026-07-14
00810142374507SoftMolecularSCC SOFT COMPUTERJQP2026-07-14
00810142374514SoftGenomicsSCC SOFT COMPUTERJQP2026-07-14
00810142374521SoftTrackSCC SOFT COMPUTERJQP2026-07-14
00810142374279SoftBiobankSCC SOFT COMPUTERJQP2026-07-07