FDA.reportPublic FDA data

Autostat II Anti-B2-Glycoprotein I IgA

Primary DI
00816879020243
Brand
Autostat II Anti-B2-Glycoprotein I IgA
Company
HYCOR BIOMEDICAL LLC
Model
FGA24
Device description
96 well ELISA for the detection of Anti-B2-Glycoprotein I IgA antibodies in human serum
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K030397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030397000AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISAHycor Biomedical , Ltd.2003-03-21MSV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816879020243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816879020243008168790202438168790202430816879020243

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
800-382-2527Customerservices-us@hycorbiomedical.com

Regulatory Flags#

DUNS number
010558476
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaF0188632330Z2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaF0368634210Z2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.F0408632420Z2026-05-29
00810053950227NOVEOS Salmon, Salmo salarF0418638910Z2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusF07563247Z2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisF2018633630Z2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraF2038632630Z2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisF2908633830Z2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaF01886323302026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.F04086324202026-05-29
00816879023886NOVEOS Pistachio Nut, Pistacia veraF20386326302026-05-29
00816879024548NOVEOS Salmon, Salmo salarF04186389102026-05-29
00816879024760NOVEOS Pecan Nut, Carya illinoensisF20186336302026-05-29
00816879025057NOVEOS Oyster, Ostrea edulisF29086338302026-05-29
00816879025149NOVEOS Egg Yolk, Gallus gallusF075632472026-05-29
00816879027372NOVEOS Coconut, Cocos nuciferaF03686342102026-05-29
00816879020212Autostat II Anti-Nuclear Antibody (ANA) ScreenFGA212016-09-26
00810053950098NOVEOS Peanut, Arachis hypogaeaF01363229Z2026-01-22
00810053950272NOVEOS Bos d 4 α-lactalbumin, MilkF076C63248Z2026-01-22
00810053950289NOVEOS Bos d 5 b-lactoglobulin, MilkF077C63249-3Z2026-01-22

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
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
04250289500869AESKULISA® ß2-Glyco-GM Aesku.Diagnostics GmbH & Co. KGMSV2016-09-27
04250289500951AESKULISA® ß2-Glyco-Check 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
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