FDA.reportPublic FDA data

Anti-Beta 2 Glycoprotein Screen ELISA

Primary DI
B24235B2SHUE010
Brand
Anti-Beta 2 Glycoprotein Screen ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
35-B2SHU-E01
Catalog number
35-B2SHU-E01
Device description
Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employing native Beta-2glycoprotein I highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against Beta-2-glycoprotein I in human serum.
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
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
B24235B2SHUE010PrimaryHIBCC0

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 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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B24211GLUHUE010Glucagon ELISA11-GLUHU-E0111-GLUHU-E012024-10-23
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B24280CALPHUIT2000ALPCO Calprotectin Immunoturbidimetric Assay80-CALPHU-IT20080-CALPHU-IT2002023-08-18
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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
04250289502849AESKULISA® ß2-Glyco-Check 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
04250289500852AESKULISA® ß2-Glyco-AAesku.Diagnostics GmbH & Co. KGMSV2016-09-27
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