FDA.reportPublic FDA data

AESKULISA® dsDNA G

Primary DI
04250289503440
Brand
AESKULISA® dsDNA G
Company
Aesku.Diagnostics GmbH & Co. KG
Model
30-7142US
Catalog number
30-7142US
Device description
AESKULISA®dsDNA-G is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. The assay is a tool in the diagnosis of systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
Published
2017-02-28
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
K041628000
K081251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041628000AESKULISA DS DNA GAesku Diagnostics2004-10-14LSW
K081251000MODIFICATION TO AESKULISA DS DNA GAesku Diagnostics2008-05-13LSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289503440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289503440042502895034404250289503440

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to double stranded DNA (anti-dsDNA) 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
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
04250289500579AESKULISA® ANA-HEp-231152016-09-27
04250289500647AESKULISA® dsDNA-G31422016-09-27
04250289502993AESKULISA® Scl-707111US7111US2017-02-28
04250289503679AESKULISA® DGP-Check35152016-09-27
04250289504843AESKULISA® DGP-Check30-7515US30-7515US2017-03-01

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
04250289510394AESKUSLIDES nDNA (Crithidia luciliae)Aesku.Diagnostics GmbH & Co. KGLSW2018-05-14
04250289503037AESKULISA® dsDNA-GAesku.Diagnostics GmbH & Co. KGLSW2017-03-17
B24235DSGHUE010Anti-ds-DNA-G ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.LSW2017-01-18
08426950624646QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.LSW2016-08-31
08426950627760QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.LSW2016-08-31