AccessGUDID - DEVICE: IMMUNO CONCEPTS (M7490081311)

GUDID

Device Identifier (DI) Information

Brand Name: IMMUNO CONCEPTS
Version or Model: 8131
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8131
Company Name: IMMUNO CONCEPTS INC

Primary DI Number: M7490081311
Issuing Agency: HIBCC
Commercial Distribution End Date: August 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 038271904 *Terms of Use

Device Description: Custom - EBNA FA BP - 3900 wells

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):	No
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?
55208	Multiple thyroid antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple antibodies to the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using a fluorescent immunoassay 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
No Product Codes

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
No Device Sizes

Device Record Status

Public Device Record Key: 15cd22f3-6e85-438a-83ac-dc05d6ced053
Public Version Date: August 12, 2025
Public Version Number: 3
DI Record Publish Date: September 24, 2016