FDA.reportPublic FDA data

TPO IgG ELISA

Primary DI
00840239027917
Brand
TPO IgG ELISA
Company
DRG International Inc
Model
EIA-2791
Catalog number
EIA-2791
Device description
The DRG Thyroid Peroxidase (TPO) IgG Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to thyroid peroxidase (TPO) in human serum. The test system is intended to be used as an aid in the diagnosis of thyroid diseases.
Published
2023-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K991610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991610000ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.Zeus Scientific, Inc.1999-06-25DDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239027917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239027917008402390279178402390279170840239027917

GMDN Terms#

Term, Definition table
TermDefinition
Multiple thyroid autoantibody 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 the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using an enzyme immunoassay (EIA) method. This test detects autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody] to aid in the diagnosis of autoimmune thyroid diseases such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease.

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
9735647555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
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
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
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
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