AccessGUDID - DEVICE: uTASWako Chip Cassette (10856626006080)

GUDID

Device Identifier (DI) Information

Brand Name: uTASWako Chip Cassette
Version or Model: 993-61601
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 993-61601
Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION

Primary DI Number: 10856626006080
Issuing Agency: GS1
Commercial Distribution End Date: October 23, 2020
Device Count: 5
Labeler D-U-N-S® Number*: 690598875 *Terms of Use

Device Description: The uTASWako chip cassette is designed to be used for the assays on the uTASWako i30.

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:	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?
47211	Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein-L3 fraction (AFP-L3) in a clinical specimen, using a fluorescent immunoassay method. It is typically used to aid in the diagnosis of hepatocellular carcinoma (HCC).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSF	Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100464	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: b0a9243b-d7ca-455f-8382-d91c3eca9219
Public Version Date: December 18, 2023
Public Version Number: 6
DI Record Publish Date: November 11, 2016