FDA.reportPublic FDA data

Autoimmune EIA

Primary DI
00847817018343
Brand
Autoimmune EIA
Company
BIO-RAD LABORATORIES, INC.
Model
425-2280
Catalog number
4252280
Device description
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) 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
MVMAutoantibodies, endomysial(tissue transglutaminase)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042644000AESKULISA TTG A AND AESKULISA TTG GAesku, Inc.2005-06-01MVM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817018343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817018343008478170183438478170183430847817018343

GMDN Terms#

Term, Definition table
TermDefinition
Tissue transglutaminase 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 antibodies to tissue transglutaminase (anti-tTG) 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
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
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