AccessGUDID - DEVICE: "TOTAL ANTIOXIDANT STATUS (TAS CONTROL)" (05055273204728)

GUDID

Device Identifier (DI) Information

Brand Name: "TOTAL ANTIOXIDANT STATUS (TAS CONTROL)"
Version or Model: NX2331
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NX2331
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273204728
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: This product is intended for use in the control of the Randox Total Antioxidant Status assay,

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:	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?
60317	Antioxidant capacity IVD, control	A material which is used to verify the performance of an assay intended to be used to determine the antioxidative capacity of a clinical specimen to neutralize free radicals.	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 [?]
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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e197f31a-45f5-48ed-801c-075f919ec10b
Public Version Date: October 03, 2022
Public Version Number: 1
DI Record Publish Date: September 23, 2022