AccessGUDID - DEVICE: Aquaporin-4 Auto-Antibody (AQP4Ab) (B126KR82000)

GUDID

Device Identifier (DI) Information

Brand Name: Aquaporin-4 Auto-Antibody (AQP4Ab)
Version or Model: KR8200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KR8200
Company Name: KRONUS, INC.

Primary DI Number: B126KR82000
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 autoantibodies to Aquaporin-4 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):	Yes
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?
58948	Immunoglobulin G subclass (IgG subclass) 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 one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PNI	Aquaporin-4 Autoantibody

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161951	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: 9764adbd-2524-488c-9da4-6f27d8c59270
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016