FDA.reportPublic FDA data

EliA Gliadin IgA Well

Primary DI
07333066014685
Brand
EliA Gliadin IgA Well
Company
Phadia AB
Model
DECC055190
Catalog number
DECC055190
Device description
EliA Gliadin IgA Well
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K063775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063775000ELIA GLIADIN IGA, IGG AND CELIAC CONTROLPhadia US, Inc.2007-03-14MST

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066010724PackageGS14In Commercial Distribution
07333066014685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066010724073330660107247333066010724
07333066014685073330660146857333066014685

GMDN Terms#

Term, Definition table
TermDefinition
Gliadin antibody IVD, kit, fluorescent immunoassayA 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 a fluorescent immunoassay 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

Contacts#

Phone, Email table
PhoneEmail
+469999999999xx@xx.xx

Regulatory Flags#

DUNS number
354019424
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333066014524EliA U1RNP WellDECC055010DECC0550102016-09-23
07333066014562EliA CENP WellDECC055050DECC0550502016-09-23
07333066014623EliA RNP70 WellDECC055110DECC0551102016-09-23
07333066014630EliA GBM WellDECC055140DECC0551402016-09-23
07333066014678EliA Celikey IgG WellDECC055180DECC0551802016-09-23
07333066014715EliA Cardiolipin IgA WellDECC055280DECC0552802016-09-23
07333066014746EliA ß2-Glycoprotein I IgA WellDECC055310DECC0553102016-09-23
07333066014777EliA PR3S WellDECC055360DECC0553602016-09-23
07333066014784EliA MPOS WellDECC055370DECC0553702016-09-23
07333066014791EliA GliadinDP IgA WellDECC055380DECC0553802016-09-23
07333066014807EliA GliadinDP IgG WellDECC055390DECC0553902016-09-23
07333066014814EliA RF IgM WellDECC056000DECC0560002016-09-23
07333066014852EliA M2 WellDECC056490DECC0564902016-09-23
07333066014593EliA Symphony WellDECC055080DECC0550802016-09-23
07333066016115EliA SymphonyS WellDECC056710DECC0567102020-06-30
07333066015798EliA CCP WellDECC066150DECC0661502026-01-29
07333066024202EliA IgG Calibrator WellDECC066090DECC0660902026-01-29
07333066024226EliA Dummy WellDECC066100DECC0661002026-01-29
07333066024240EliA IgA Calibrator WellDECC066160DECC0661602026-01-29
07333066024271EliA IgM Calibrator WellDECC066270DECC0662702026-01-29

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