FDA.reportPublic FDA data

Gliadin IgG ELISA

Primary DI
04048474033717
Brand
Gliadin IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-3371
Catalog number
EIA-3371
Device description
The DRG Gliadin IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to gliadin in human serum. The test system is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease
Published
2023-08-29
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
MSTAntibodies, Gliadin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSTAntibodies, GliadinImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990204000GLIADIN IGG ELISA TEST SYSTEMZeus Scientific, Inc.1999-03-26MST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474033717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474033717040484740337174048474033717

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. This test is intended to be used as an aid in the diagnosis of Coeliac disease.

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
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
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
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10
04048474035643Anti-dsDNA IgM ELISAEIA-3564EIA-35642019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474033700Gliadin IgA 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
00845714002960IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.MST2016-10-27