AccessGUDID - DEVICE: QMedix™ (00850054026729)

GUDID

Device Identifier (DI) Information

Brand Name: QMedix™
Version or Model: DACDURS-10 (100)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: URS-10
Company Name: Diagnostic Automation, Inc.

Primary DI Number: 00850054026729
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878252071 *Terms of Use

Device Description: QMedix™URS-10 InstaTest is intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period of time.

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:	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?
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
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)
JRE	Refractometer For Clinical Use
JIO	Blood, Occult, Colorimetric, In Urine
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJX	Test, Urine Leukocyte

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 STRIPS

Device Record Status

Public Device Record Key: 21d1d0ee-06d6-4919-a836-6a6d7113a464
Public Version Date: November 06, 2024
Public Version Number: 1
DI Record Publish Date: October 29, 2024