AccessGUDID - DEVICE: Pointe Scientific, Inc. (00811727012791)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Scientific, Inc.
Version or Model: HU982-615
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HU982-615
Company Name: HORIBA INSTRUMENTS INCORPORATED

Primary DI Number: 00811727012791
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052845583 *Terms of Use

Device Description: Uric Acid Reagent, for the quantitative determination of uric acid in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 5 x 100mL, 5 x 23mL

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:	No
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?
53586	Uric 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 uric acid in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNK	Acid, Uric, Uricase (Colorimetric)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970560	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d03290db-6c0a-47aa-8355-df82b9daed8c
Public Version Date: October 02, 2025
Public Version Number: 4
DI Record Publish Date: August 31, 2016