FDA.reportPublic FDA data

AESKUSLIDES nDNA (Crithidia luciliae)

Primary DI
04250289510394
Brand
AESKUSLIDES nDNA (Crithidia luciliae)
Company
Aesku.Diagnostics GmbH & Co. KG
Model
53.100.US
Device description
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum. This in vitro diagnostic assay is used as an aid for the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. The assay can be processed manually and analyzed at the microscope or processed and analyzed with HELIOS® Automated IFA System. All suggested results obtained with the HELIOS® Automated IFA System must be confirmed by trained personnel.
Published
2018-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LSWAnti-Dna Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSWAnti-Dna Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172348000AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10Aesku.Diagnostics GmbH & Co. KG2018-02-16LSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289510394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289510394042502895103944250289510394

GMDN Terms#

Term, Definition table
TermDefinition
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify002-8°C

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
04250289504935AESKUSLIDES® ANA-HEp-2 gamma 51.101.US51.101.US2017-02-28
04250289510387AESKUSLIDES ANCA Formalin54.051.US2018-05-25
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
04250289513401AESKUSLIDES® nDNA (Crithidia luciliae)Aesku.Diagnostics GmbH & Co. KGLSW2024-11-15
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LSW2023-12-14
00894175000237AccuDiag ™Diagnostic Automation, Inc.LSW2021-08-06
07333066019406EliA dsDNA WellPhadia ABLSW2019-03-06
07333066010557EliA dsDNA WellPhadia ABLSW2019-03-06
04250289503037AESKULISA® dsDNA-GAesku.Diagnostics GmbH & Co. KGLSW2017-03-17
04250289503440AESKULISA® dsDNA GAesku.Diagnostics GmbH & Co. KGLSW2017-02-28
B24235DSGHUE010Anti-ds-DNA-G ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.LSW2017-01-18
04250289500647AESKULISA® dsDNA-GAesku.Diagnostics GmbH & Co. KGLSW2016-09-27
08426950624646QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.LSW2016-08-31
08426950627760QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.LSW2016-08-31