AccessGUDID - DEVICE: uTASWako DCP Control H (10856626006066)

GUDID

Device Identifier (DI) Information

Brand Name: uTASWako DCP Control H
Version or Model: 991-61401
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 991-61401
Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION

Primary DI Number: 10856626006066
Issuing Agency: GS1
Commercial Distribution End Date: October 23, 2020
Device Count: 4
Labeler D-U-N-S® Number*: 690598875 *Terms of Use

Device Description: In-Vitro Diagnostic Use

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?
47214	Des-gamma-carboxyprothrombin (DCP) IVD, control	A material used to verify the performance of an assay intended to qualitatively and/or quantitatively detect des-gamma-carboxyprothrombin (DCP) [protein induced by vitamin K absence-II (PIVKA-II)] in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

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
Storage Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 050d5997-0c81-4438-98e3-1ed799c1c157
Public Version Date: October 26, 2020
Public Version Number: 5
DI Record Publish Date: November 25, 2016