AccessGUDID - DEVICE: HR Series NEFA-HR(2) Color Reagent A (14987481164601)

GUDID

Device Identifier (DI) Information

Brand Name: HR Series NEFA-HR(2) Color Reagent A
Version or Model: 999-34691
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 999-34691
Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION

Primary DI Number: 14987481164601
Issuing Agency: GS1
Commercial Distribution End Date:
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?
53379	Non-esterified fatty acid IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of non-esterified fatty acid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JLH	Titrimetric, Fatty Acids

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 83e69105-2f32-4c21-8a0d-d5a347e58fe4
Public Version Date: June 09, 2021
Public Version Number: 1
DI Record Publish Date: June 01, 2021