FDA.reportPublic FDA data

Autoimmune EIA

Primary DI
00847817018329
Brand
Autoimmune EIA
Company
BIO-RAD LABORATORIES, INC.
Model
425-2240
Catalog number
4252240
Device description
Autoimmune EIA Anti-Gliadin IgG
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSTAntibodies, gliadin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSTAntibodies, GliadinImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052439000AESKULISA GLIA A AND AESKULISA GLIA GAesku Diagnostics2006-02-07MST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817018329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817018329008478170183298478170183290847817018329

GMDN Terms#

Term, Definition table
TermDefinition
Gliadin 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 anti-gliadin antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
+1(800)224-6723TechSupport.USSD@bio-rad.com

Regulatory Flags#

DUNS number
884513334
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474033700Gliadin IgA ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMST2023-08-29
04048474033717Gliadin IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMST2023-08-29
00840239033703Gliadin IgA ELISA DRG International IncMST2023-08-24
00840239033710Gliadin IgG ELISA DRG International IncMST2023-08-24
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MST2022-05-27
00894175000428AccuDiag ™Diagnostic Automation, Inc.MST2021-08-06
00847865013000BioPlex 2200BIO-RAD LABORATORIES, INC.MST2020-01-30
07333066019901ImmunoCAP Gliadin IgA/IgG Control LowPhadia ABMST2019-03-29
07333066019918ImmunoCAP Gliadin IgA Control HighPhadia ABMST2019-03-29
07333066019925ImmunoCAP Gliadin IgG Control HighPhadia ABMST2019-03-29
07333066000701ImmunoCAP Gliadin IgA/IgG Control LowPhadia ABMST2019-03-29
07333066000718ImmunoCAP Gliadin IgA Control HighPhadia ABMST2019-03-29
07333066000725ImmunoCAP Gliadin IgG Control HighPhadia ABMST2019-03-29
07333066019819ImmunoCAP Specific IgA/IgG Sample DiluentPhadia ABMST2019-03-28
07333066000732ImmunoCAP Specific IgA/IgG Sample DiluentPhadia ABMST2019-03-28
07333066019550ImmunoCAP Specific IgA CalibratorsPhadia ABMST2019-03-26
07333066019574ImmunoCAP Specific IgA Curve ControlsPhadia ABMST2019-03-26
00845714002663Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MST2017-09-26
00845714002670Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.MST2017-09-26
04250289502863AESKULISA® Glia-G Aesku.Diagnostics GmbH & Co. KGMST2017-03-17
04250289503105AESKULISA® Glia-A Aesku.Diagnostics GmbH & Co. KGMST2017-03-17
04250289503112AESKULISA® Glia-G Aesku.Diagnostics GmbH & Co. KGMST2017-03-17
04250289504843AESKULISA® DGP-CheckAesku.Diagnostics GmbH & Co. KGMST2017-03-01
04250289502856AESKULISA® Glia-A Aesku.Diagnostics GmbH & Co. KGMST2017-02-28
04250289504584AESKULISA® DGP-A Aesku.Diagnostics GmbH & Co. KGMST2017-02-28
04250289504591AESKULISA® DGP-G Aesku.Diagnostics GmbH & Co. KGMST2017-02-28
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MST2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MST2016-12-09
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MST2016-12-09