AccessGUDID - DEVICE: KRONUS GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY ELISA ASSAY KIT (B126KR77100)

GUDID

Device Identifier (DI) Information

Brand Name: KRONUS GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY ELISA ASSAY KIT
Version or Model: KR7710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KR7710
Company Name: KRONUS, INC.

Primary DI Number: B126KR77100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 181070814 *Terms of Use

Device Description: An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody 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?
54916	Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to glutamic acid decarboxylase (anti-GAD) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used as a predictive marker for the progression of autoimmune diabetes and the eventual onset of insulin-dependent diabetes mellitus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWG	Autoantibodies, Glutamic Acid Decarboxylase (Gad)

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: d23f6839-aaa1-4093-9282-8f39218e685a
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: September 23, 2016