AccessGUDID - DEVICE: ANTI-THYROGLOBULIN TEST KIT (TgAb) (B126KR62750)

GUDID

Device Identifier (DI) Information

Brand Name: ANTI-THYROGLOBULIN TEST KIT (TgAb)
Version or Model: KR6275
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KR6275
Company Name: KRONUS, INC.

Primary DI Number: B126KR62750
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 181070814 *Terms of Use

Device Description: A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.

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?
55198	Thyroglobulin antibody IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroglobulin in a clinical specimen, using a radioimmunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZO	System, Test, Thyroid Autoantibody

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: cefa8c64-bb8b-45d1-bdf4-98bf714a81ee
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016