FDA.reportPublic FDA data

NA

Primary DI
05056080500034
Brand
NA
Company
REMEL EUROPE LIMITED
Model
R30850601
Published
2016-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DDCThyroglobulin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DDCThyroglobulin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K780874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K780874000THYMUNE-TBurroughs Wellcome Co.1978-06-14DDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080500034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080500034050560805000345056080500034

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin antibody IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroglobulin in a clinical specimen, using an agglutination method. It is used in the diagnosis and monitoring of autoimmune thyroid diseases, such as autoimmune thyroiditis (Hashimoto’s disease).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401322295600ITechnicalSupport@remel.com

Regulatory Flags#

DUNS number
232600853
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumR301639012026-05-05
05056080501024NAR301650012016-12-09
05056080501888Wellcolex E.coli O157R309595012021-07-21
05056080501598Proteus OX2 Agglutinating SerumR301657012021-07-21
05056080500065NAR308550012016-09-24
05056080500126NAR308553012016-09-24
05056080500317NAR309577012016-09-24
05056080500324NAR309578012016-09-24
05056080500331NAR309579012016-09-24
05056080500348NAR309580012016-09-24
05056080500379NAR309583012016-09-24
05056080500409NAR309586012016-09-24
05056080500591NAR301606012016-09-24
05056080500607NAR301607012016-09-24
05056080500614NAR301608012016-09-24
05056080500638NAR301610012016-09-24
05056080500645NAR301611012016-09-24
05056080500652NAR301612012016-09-24
05056080500713NAR301618012016-09-24
05056080500768NAR301623012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474041101Anti-Thyroglobulin (Anti-Tg) ELISADRG Instruments Gesellschaft mit beschränkter HaftungDDC2023-08-31
04048474027914TPO IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungDDC2023-08-29
00840239027894Cardiolipin IgM ELISADRG International IncDDC2023-08-24
00840239027917TPO IgG ELISADRG International IncDDC2023-08-24
00840239041104Anti-Thyroglobulin (Anti-Tg) ELISADRG International IncDDC2019-03-20
00816870020389Anti-Tg AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DDC2019-02-11
00816870022062Anti-Tg AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DDC2019-02-11
05056080500027NAREMEL EUROPE LIMITEDDDC2016-12-09
00816879020038Autostat II Anti-ThyroglobulinHYCOR BIOMEDICAL LLCDDC2016-09-26
08426950454465QUANTA Lite® Thyroid T ELISAINOVA DIAGNOSTICS, INC.DDC2016-08-31
00850487007241ReQuest QUEST INTERNATIONAL, INC.DDC2016-08-31
00850487007494SeraQuestQUEST INTERNATIONAL, INC.DDC2016-08-31