AccessGUDID - DEVICE: Anti-Thyroglobulin (Anti-Tg) ELISA (04048474041101)

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 Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 04048474041101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device Description: The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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 [?]
K971835	000

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 065d566f-e099-4bbe-b617-043c4a70c8b0
Public Version Date: October 18, 2023
Public Version Number: 2
DI Record Publish Date: August 31, 2023