FDA.reportPublic FDA data

Anti-Thyroglobulin (Anti-Tg) ELISA

Primary DI
00840239041104
Brand
Anti-Thyroglobulin (Anti-Tg) ELISA
Company
DRG International Inc
Model
EIA-4110
Catalog number
EIA-4110
Device description
The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.
Published
2019-03-20
Public version status
Update
Distribution status
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
K971835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971835000ANTI-THYROGLOBULIN (TG) MICROPLATE ELISAMonobind1997-07-03DDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239041104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239041104008402390411048402390411040840239041104

GMDN Terms#

Term, Definition table
TermDefinition
Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal 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 both thyroglobulin and thyroid peroxidase (anti-TPO; also known as anti-microsomal antibody) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Total Volume1Milliliter
Total Volume7Milliliter
Total Volume8Milliliter
Total Volume13Milliliter
Total Volume20Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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
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
05056080500034NAREMEL 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