AccessGUDID - DEVICE: URiSCAN 2 ACR strip (08806125680224)

GUDID

Device Identifier (DI) Information

Brand Name: URiSCAN 2 ACR strip
Version or Model: U643
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: YD Diagnostics CORP.

Primary DI Number: 08806125680224
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687769737 *Terms of Use

Device Description: Urinalysis dip and read strips for URiSCAN urine analyzer. Test for Microalbumin and Creatinine in urine.

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):	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?
54514	Multiple urine analyte IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JFY	Enzymatic Method, Creatinine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141874	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 739cc659-36d1-4236-83a2-d1294ec84b83
Public Version Date: November 28, 2022
Public Version Number: 5
DI Record Publish Date: August 05, 2016