AccessGUDID - DEVICE: URiSCAN Optima (08806125619033)

GUDID

Device Identifier (DI) Information

Brand Name: URiSCAN Optima
Version or Model: Optima
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: YD Diagnostics CORP.

Primary DI Number: 08806125619033
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687769737 *Terms of Use

Device Description: The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN urine test strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN urine test strips and to display and print the results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders.

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?
57860	Urine analyser IVD, laboratory, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KQO	Automated Urinalysis System

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: 760c5dbf-d88f-41da-92b2-ce3b2770a1b6
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 05, 2016