FDA.reportPublic FDA data

Anti-Cardiolipin-A ELISA

Primary DI
B24235CAAHUE010
Brand
Anti-Cardiolipin-A ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
35-CAAHU-E01
Catalog number
35-CAAHU-E01
Device description
The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human Beta-2-glycoprotein I (Beta-2-GPI) for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and Beta-2-GPI which are only expressed when Beta-2-GPI interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjunction with other serological tests and clinical findings.
Published
2017-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
B24235CAAHUE010PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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B24280CALPHUIT2000ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT20080-CALPHU-IT2002023-08-18
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Primary DI, Brand, Company table
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08430793040853Aptiva® APS IgM ReagentINOVA DIAGNOSTICS, INC.MID2024-03-11
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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
04250289503044AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2017-02-28
04250289503051AESKULISA® Cardiolipin-A Aesku.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
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00845714002953IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MID2016-11-15
04250289500821AESKULISA® Cardiolipin-Check Aesku.Diagnostics GmbH & Co. KGMID2016-09-27
04250289500838AESKULISA® Cardiolipin-A Aesku.Diagnostics GmbH & Co. KGMID2016-09-27
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