FDA.reportPublic FDA data

AESKULISA® ß2-Glyco-Check

Primary DI
04250289502849
Brand
AESKULISA® ß2-Glyco-Check
Company
Aesku.Diagnostics GmbH & Co. KG
Model
30-7215US
Catalog number
30-7215US
Device description
AESKULISA® ß2-Glyco-Check is a solid phase enzyme immunoassay employing native ß2-glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against ß2-glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062217000AESKULSKA BETA2-GLYCO-AAesku, Inc.2006-12-13MSV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289502849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289502849042502895028494250289502849

GMDN Terms#

Term, Definition table
TermDefinition
Beta-2-glycoprotein I 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 beta-2-glycoprotein I in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
341714388
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250289502894AESKULISA® ASCA-A30-7507US30-7507US2017-02-28
04250289502979AESKULISA® SS-A7107US7107US2017-02-28
04250289503006AESKULISA® Cenp-B7112US7112US2017-02-28
04250289504584AESKULISA® DGP-A30-7513US30-7513US2017-02-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426951011216HemosIL CL Anti-ß2 Glycoprotein-I IgMINSTRUMENTATION LABORATORY COMPANYMSV2026-04-08
08430793040716Aptiva® APS IgG ReagentINOVA DIAGNOSTICS, INC.MSV2024-03-11
08430793040853Aptiva® APS IgM ReagentINOVA DIAGNOSTICS, INC.MSV2024-03-11
08426951289257QUANTA Flash® B2GP1 IgA ReagentsINOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951289264QUANTA Flash® B2GP1 IgG Reagents INOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951289271QUANTA Flash® B2GP1 IgM ReagentsINOVA DIAGNOSTICS, INC.MSV2019-09-27
08426951298778HemosIL AcuStar Anti-B2GPI Domain 1INSTRUMENTATION LABORATORY COMPANYMSV2018-07-17
B24235B2SHUE010Anti-Beta 2 Glycoprotein Screen ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MSV2017-08-28
00845714002427Immco Diagnostics, IncIMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002434Immco DIagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002441Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
00845714002458Immco DIagnostics, Inc.IMMCO DIAGNOSTICS, INC.MSV2017-07-11
04250289503082AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2017-03-02
04250289503075AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2017-03-01
04250289502825AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289502832AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
04250289503099AESKULISA® ß2-Glyco-Check Aesku.Diagnostics GmbH & Co. KGMSV2017-02-28
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MSV2016-12-09
00845714002939IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MSV2016-10-27
04250289500869AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2016-09-27
00816879020229Autostat II Anti-B2-Glycoprotein I IgGHYCOR BIOMEDICAL LLCMSV2016-09-26
00816879020236Autostat II Anti-B2-Glycoprotein I IgMHYCOR BIOMEDICAL LLCMSV2016-09-26
00816879020243Autostat II Anti-B2-Glycoprotein I IgAHYCOR BIOMEDICAL LLCMSV2016-09-26
00845714004353IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MSV2016-09-24
07333066014746EliA ß2-Glycoprotein I IgA WellPhadia ABMSV2016-09-23
07333066014753EliA ß2-Glycoprotein I IgG WellPhadia ABMSV2016-09-23
07333066014760EliA ß2-Glycoprotein I IgM WellPhadia ABMSV2016-09-23
08426950496977HemosIL AcuStar Anti-B2 Glycoprotein-I IgGINSTRUMENTATION LABORATORY COMPANYMSV2016-09-23
08426950496984HemosIL AcuStar Anti-B2 Glycoprotein-I IgMINSTRUMENTATION LABORATORY COMPANYMSV2016-09-23
07333066010786EliA ß2-Glycoprotein I IgA WellPhadia ABMSV2016-09-23