FDA.reportPublic FDA data

AESKULISA® Cardiolipin-GM

Primary DI
04250289500845
Brand
AESKULISA® Cardiolipin-GM
Company
Aesku.Diagnostics GmbH & Co. KG
Model
3204
Device description
AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2glycoprotein I which are only expressed when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE).
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
MIDSystem, Test, Anticardiolipin Immunological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIDSystem, Test, Anticardiolipin ImmunologicalImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040463000AESKULISA CARDIOLIPIN AGMAesku, Inc.2004-05-12MID

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289500845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289500845042502895008454250289500845

GMDN Terms#

Term, Definition table
TermDefinition
Anticardiolipin antibody 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 one or multiple classes of antibodies to cardiolipin 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
08426951011193HemosIL CL Anti-Cardiolipin IgMINSTRUMENTATION LABORATORY COMPANYMID2026-04-08
08430793040716Aptiva® APS IgG ReagentINOVA DIAGNOSTICS, INC.MID2024-03-11
08430793040853Aptiva® APS IgM ReagentINOVA DIAGNOSTICS, INC.MID2024-03-11
04048474027884Cardiolipin IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
04048474027891Cardiolipin IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
04048474027907Cardiolipin IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
04048474035889Anti-Cardiolipin IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2023-08-29
00840239035875Anti-Cardiolipin IgG/IgM ELISADRG International IncMID2023-08-25
00840239035882Anti-Cardiolipin IgA ELISADRG International IncMID2023-08-25
00840239035899Anti-Cardiolipin Screen ELISADRG International IncMID2023-08-25
00840239027887Cardiolipin IgG ELISADRG International IncMID2023-08-24
00840239027900Cardiolipin IgA ELISADRG International IncMID2023-08-24
07333066014197EliA APS Positive Control 2500/5000Phadia ABMID2020-12-09
08426951289240QUANTA Flash® aCL IgM ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
08426951289288QUANTA Flash® aCL IgA ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
08426951289295QUANTA Flash® aCL IgG ReagentsINOVA DIAGNOSTICS, INC.MID2019-09-27
04048474035872Anti-Cardiolipin IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
04048474035896Anti-Cardiolipin Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
00404847435870Anti-Cardiolipin IgG/IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
00404847435894Anti-Cardiolipin Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungMID2019-06-10
B24235CAAHUE010Anti-Cardiolipin-A ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MID2017-08-28
04250289503044AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
04250289503051AESKULISA® Cardiolipin-AAesku.Diagnostics GmbH & Co. KGMID2017-02-28
04250289503068AESKULISA® Cardiolipin-GM Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-12-09
00845714002823IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-11-15
00845714002953IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-11-15
04250289500821AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2016-09-27
00816879020151Autostat II Anti-Cardiolipin IgGHYCOR BIOMEDICAL LLCMID2016-09-26