AccessGUDID - DEVICE: NA (05056080500027)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: R30850501
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REMEL EUROPE LIMITED

Primary DI Number: 05056080500027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 232600853 *Terms of Use

Device Description: No description.

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:	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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid peroxidase (anti-TPO), also known as anti-microsomal antibody, in a clinical specimen, using an agglutination method. It is used in the diagnosis of autoimmnune thyroid diseases, such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease.

GMDN Preferred Term Name

GMDN Definition

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, agglutination

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid peroxidase (anti-TPO), also known as anti-microsomal antibody, in a clinical specimen, using an agglutination method. It is used in the diagnosis of autoimmnune thyroid diseases, such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease.

FDA Product Code

[?]

Product Code	Product Code Name
DDC	Thyroglobulin, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K780873	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f6915a9e-e1f0-492e-ab46-8c734f83c984
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 09, 2016