AccessGUDID - DEVICE: Anti-Thyroglobulin (Anti-Tg) ELISA (00840239041104)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-Thyroglobulin (Anti-Tg) ELISA
Version or Model: EIA-4110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-4110
Company Name: DRG International Inc

Primary DI Number: 00840239041104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55209	Multiple thyroid 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 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DDC	THYROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 20 Milliliter
Device Size Text, specify: Wash Solution
Device Size Text, specify: Calibrators
Total Volume: 13 Milliliter
Device Size Text, specify: Stop Solution
Total Volume: 1 Milliliter
Device Size Text, specify: Substrate B
Device Size Text, specify: Biotin Reagent
Device Size Text, specify: Substrate A
Total Volume: 7 Milliliter
Device Size Text, specify: Enzyme Reagent
Total Volume: 8 Milliliter
Device Size Text, specify: Serum Diluent

Device Record Status

Public Device Record Key: 85b324fc-aa68-4ede-87ef-c6a55cc8a748
Public Version Date: October 18, 2023
Public Version Number: 6
DI Record Publish Date: March 20, 2019