FDA.reportPublic FDA data

IFA: Oesophagus (Monkey) IgA EUROPattern

Primary DI
04049016161622
Brand
IFA: Oesophagus (Monkey) IgA EUROPattern
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FC 1911-2010-11 A
Published
2025-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K061408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061408000EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KITEuroimmun Us, LLC2006-10-05MVM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016161622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016161622040490161616224049016161622

GMDN Terms#

Term, Definition table
TermDefinition
Endomysium antibody (EMA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-endomysial antibodies (anti-EMA) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
322209263
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
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24
04049016099031IFA 40: HEp-20-10FA 1522-2010-12016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333066024240EliA IgA Calibrator WellPhadia ABMVM2026-01-29
07333066023977EliA 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
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