AccessGUDID - DEVICE: NA (05056080500027)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: R30850501
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: REMEL EUROPE LIMITED

Primary DI Number: 05056080500027
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2023
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62368	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 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 [?]
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: February 16, 2024
Public Version Number: 5
DI Record Publish Date: December 09, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4401322295600
Email: ITechnicalSupport@remel.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES