FDA.reportPublic FDA data

EliA IgA Calibrator Well

Primary DI
07333066023977
Brand
EliA IgA Calibrator Well
Company
Phadia AB
Model
DECC066160
Catalog number
DECC066160
Device description
EliA IgA Calibrator Well
Published
2026-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVMAutoantibodies, endomysial(tissue transglutaminase)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVMAutoantibodies, Endomysial(Tissue Transglutaminase)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062787000ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01Phadia US, Inc.2006-12-29MVM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066023977PackageGS14In Commercial Distribution
07333066024240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066023977073330660239777333066023977
07333066024240073330660242407333066024240

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin A (IgA total) 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 total immunoglobulin A (IgA total) 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
+469999999999xx@xx.xx

Regulatory Flags#

DUNS number
354019424
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07333066024240EliA IgA Calibrator WellPhadia ABMVM2026-01-29
04049016161592IFA: Oesophagus (Monkey) IgAEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161608IFA: Oesophagus (Monkey) IgAEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161615IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
04049016161622IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2025-10-21
00845533002011Endomysium (Primate esophagus)ZEUS SCIENTIFIC, INC.MVM2025-10-17
04049016144595IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2024-05-17
08430793040471Aptiva® Celiac Disease IgG ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
08430793040532Aptiva® Celiac Disease IgA ReagentINOVA DIAGNOSTICS, INC.MVM2022-05-27
07333066014180EliA Celiac Positive Control 2500/5000Phadia ABMVM2020-12-09
00813545026707MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545026714MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027070MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027087MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027094MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027100MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027117MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00813545027216MeDiCaSCIMEDX CORPORATIONMVM2020-12-01
00847865013000BioPlex 2200BIO-RAD LABORATORIES, INC.MVM2020-01-30
07333066020075EliA IgA CalibratorsPhadia ABMVM2019-03-26
04049016027287Anti-tissue Transglutaminase ELISA (IgA)EUROIMMUN Medizinische Labordiagnostika AGMVM2019-03-06
04049016027294Anti-tissue Transglutaminase ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMVM2019-03-06
04049016119951IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
04049016119968IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
04049016119975IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
04049016119982IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
04049016119999IFA: Oesophagus (Monkey) IgA EUROPatternEUROIMMUN Medizinische Labordiagnostika AGMVM2018-01-24
B24235TGAHUE010Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.MVM2017-05-23
04250289503129AESKULISA tTg-A New Generation Aesku.Diagnostics GmbH & Co. KGMVM2017-03-17
04250289503136AESKULISA tTg-G New Generation Aesku.Diagnostics GmbH & Co. KGMVM2017-03-17