FDA.reportPublic FDA data

AESKUSLIDES® ANA-HEp-2 gamma

Primary DI
04250289504935
Brand
AESKUSLIDES® ANA-HEp-2 gamma
Company
Aesku.Diagnostics GmbH & Co. KG
Model
51.101.US
Catalog number
51.101.US
Device description
AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.
Published
2017-02-28
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
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120889000AESKUSLIDES ANA HEP-2Aesku Diagnostics2012-10-15DHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289504935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289504935042502895049354250289504935

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassayA 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 a fluorescent immunoassay method.

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
04250289500449AESKULISA® ENA-6S 31022016-09-27
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
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
04250289504942AESKUSLIDES® ANA HEp-2-GammaAesku.Diagnostics GmbH & Co. KGDHN2025-05-27
04250289513487AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
04250289513562AESKUSLIDES® ANA-HEp-2 gamma Aesku.Diagnostics GmbH & Co. KGDHN2025-04-06
08059304340215dIFine ANA HEp-2 ClassifierVISIA LAB SRLDHN2024-11-08
G5229023441ANA/HEp-2 IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023451ANA/HEp-2 IgG IFA 180 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023601ANA/HEp-2 IgG IFA 600 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023701ANA/HEp-2 IgG IFA 1200 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229023901ANA/HEp-2 IgG IFA 120 TestHemagen Diagnostics, Inc.DHN2023-10-05
G5229024201Anti-nDNA IgG IFA 96 TestHemagen Diagnostics, Inc.DHN2023-10-05
08059304340109dIFine Automated Microscope VISIA LAB SRLDHN2022-09-07
00813545026561MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026578MeDiCaSCIMEDX CORPORATIONDHN2020-12-01
00813545026905MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
00813545026912MeDiCaSCIMEDX CORPORATIONDHN2020-11-04
04260186125096HELIOSAesku.Systems GmbH & Co. KGDHN2020-03-02
00845714002045Immco Diagnostics, IncIMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714002052Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714002069Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714004100Immco Diagnostics Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
00845714004117Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.DHN2018-07-03
04049016135722IFA 40: HEp-20-10 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGDHN2018-05-17
04049016135739IFA 40: HEp-20-10 EUROPatternEUROIMMUN Medizinische Labordiagnostika AGDHN2018-05-17
04250289503020AESKULISA® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-03-02
04250289503501AESKULISA® ANA HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
04250289504461AESKUSLIDES® ANA-HEp-2 Aesku.Diagnostics GmbH & Co. KGDHN2017-02-28
10862534000331nDNA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000300ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000317ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20
10862534000324ANA Test Kit ANTIBODIES INCORPORATEDDHN2016-12-20