AccessGUDID - DEVICE: IMMUNO-TROL (03760170782072)

GUDID

Device Identifier (DI) Information

Brand Name: IMMUNO-TROL
Version or Model: THYRO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HM 065US-2X05
Company Name: THERADIAG SA

Primary DI Number: 03760170782072
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 391123478 *Terms of Use

Device Description: Reagent, prepared from human serum, intended for use as an unassayed precision control for determination of the following autoantibodies: anti-thyroperoxidase TPO , anti-thyroglobulin TG , anti- TSH receptor R-TSH .

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?
55211	Multiple thyroid antibody IVD, control	A material which is used to verify the performance of an assay 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. Assayed antibodies include autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody].	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: Yes 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: 7ac26afa-1616-47e2-94d6-629a6fd7cacc
Public Version Date: October 18, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2018