Device
URISCREEN is a rapid screening test for UTI. The test is primarily intended for the screening of asymptomatic populations for significant bacteriuria, hematuria, pyuria and the pre...
Manufacturer
SAVYON DIAGNOSTICS LTD
SAVYON DIAGNOSTICS LTD
Model: 101-01
DI: 07290013348531
Status: New
MRI: MR Safe
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-29
Current Version: 2026-05-07
Description
URISCREEN is a rapid screening test for UTI. The test is primarily intended for the screening of asymptomatic populations for significant bacteriuria, hematuria, pyuria and the presence of other somatic cells in urine.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c8fccffd-3ae5-45e7-a873-3f32184ec56f
Distribution Status:
In Commercial Distribution
DUNS Number:
533708202
Device Count:
20
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
07290013348531
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
17290013348538
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 43539
Name: Urine catalase IVD, kit, rapid colorimetric, clinical
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for catalase 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. It is not intended to be used for self-testing.
FDA Product Codes
JXA
Kit, Screening, Urine
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
10
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
28
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
10
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
28
Item #2 - Storage Handling Type:
Handling Environment Temperature