AccessGUDID - DEVICE: Uric Acid Reagent (00812137012050)

GUDID

Device Identifier (DI) Information

Brand Name: Uric Acid Reagent
Version or Model: 500mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 501-418
Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Primary DI Number: 00812137012050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 048144997 *Terms of Use

Device Description: For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. The determination of uric acid in serum is most commonly performed for the diagnosis of gout. Increased uric acid levels are also found in leukemia, polycythemia, familial idiopathic hyperuricemia, and conditions associated with decreased renal function.

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):	No
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?
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 [?]
Premarket Submission Number Not Available/Not Released

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: b88337ce-f3a8-4957-ae2c-d692d35c2b8a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 12, 2016