FDA.reportPublic FDA data

AESKULISA® ENA-6S

Primary DI
04250289500449
Brand
AESKULISA® ENA-6S
Company
Aesku.Diagnostics GmbH & Co. KG
Model
3102
Device description
AESKULISA ENA-6S is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. Each well is coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases.
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LLLExtractable Antinuclear Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041753000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041753000AESKULISA ENA 6 SAesku Diagnostics2004-07-14LLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289500449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289500449042502895004494250289500449

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341714388
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250289503440AESKULISA® dsDNA G30-7142US30-7142US2017-02-28
04250289503501AESKULISA® ANA HEp-2 30-7115US30-7115US2017-02-28
04250289504942AESKUSLIDES® ANA HEp-2-Gamma51.101.US.Bulk551.101.US.Bulk52025-05-27
04250289513487AESKUSLIDES® ANA-HEp-2 gamma 51.181.US51.181.US2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma 51.181.US.BULK551.181.US.BULK52025-04-06
04250289500005AESKUSLIDES® ANA-HEp-2 51.1002016-09-27
04250289500425AESKULISA® ANA-8Pro 31012016-09-27
04250289500456AESKULISA® ENA-6Pro 31032016-09-27
04250289500579AESKULISA® ANA-HEp-2 31152016-09-27
04250289502917AESKULISA® ANA-8Pro 7101US7101US2017-02-28
04250289502924AESKULISA® ENA-6S 7102US7102US2017-02-28
04250289502931AESKULISA® ENA-6Pro 7103US7103US2017-02-28
04250289503020AESKULISA® ANA-HEp-2 7115US7115US2017-03-02
04250289504461AESKUSLIDES® ANA-HEp-2 51.100.US51.100.US2017-02-28
04250289504935AESKUSLIDES® ANA-HEp-2 gamma 51.101.US51.101.US2017-02-28
04250289510387AESKUSLIDES ANCA Formalin54.051.US2018-05-25
04250289510394AESKUSLIDES nDNA (Crithidia luciliae)53.100.US2018-05-14
04250289513531HELMED® Automated IFA ProcessorREF.HEL-1000.USREF.HEL-1000.US2025-01-03
04260186120008HELIOS® Automated IFA SystemREF.IOS-1000.USREF.IOS-1000.US2025-01-03
04250289512541HELIOS® AUTOMATED IFA SYSTEMREF.IOS-1000REF.IOS-10002023-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA Diagnostic Automation, Inc.LLL2026-02-27
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LLL2023-12-14
04048474039016ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-31
04048474027730ANA Screen IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-29
00840239039019ENA-6-Profile ELISADRG International IncLLL2023-08-25
00840239035714ENA Screen ELISADRG International IncLLL2023-08-24
00840239027733ANA Screen IgG ELISA DRG International IncLLL2023-08-23
B3507202500Gold Standard Diagnostics Is-anti-SS-A ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202600Gold Standard Diagnostics Is-anti-SS-B ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202700Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202900Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202400Gold Standard Diagnostics Is-anti-Sm ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-03
B3507202800Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test KitGold Standard Diagnostics CorporationLLL2020-07-27
07333066016115EliA SymphonyS WellPhadia ABLLL2020-06-30
07333066016108EliA SymphonyS WellPhadia ABLLL2020-06-30
05391516746854Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-27
05391516746762Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-26
05391516746809Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-26
04048474035711ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
00404847435719ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
08426950793182QUANTA Flash® HMGCR ReagentsINOVA DIAGNOSTICS, INC.LLL2018-10-31
08426950595786QUANTA Flash® SS-B ReagentsINOVA DIAGNOSTICS, INC.LLL2017-08-28
04250289502924AESKULISA® ENA-6S Aesku.Diagnostics GmbH & Co. KGLLL2017-02-28
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-12-09
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-12-09
00845714002960IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-10-27
10080196000616MedlineMEDLINE INDUSTRIES, INC.LLL2016-10-14
00816879020144Autostat II ENA-6 ScreenHYCOR BIOMEDICAL LLCLLL2016-09-26
00816879020298Autostat II Anti-SS-A/RoHYCOR BIOMEDICAL LLCLLL2016-09-26