Device
Diaslide Urine Culture Device (UCD) is a semi-quantitative screening culture device for detecting, enumerating and identifying specific bacteria in urine. The device is intended fo...
Manufacturer
SAVYON DIAGNOSTICS LTD
SAVYON DIAGNOSTICS LTD
Model: DS-105
DI: 07290006418111
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
Diaslide Urine Culture Device (UCD) is a semi-quantitative screening culture device for detecting, enumerating and identifying specific bacteria in urine. The device is intended for use in physician’s office laboratories and clinical laboratories as an aid in the diagnosis of urinary tract infection (UTI).
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e8f5a5c5-e48b-4cdc-89de-6e341d805e91
Distribution Status:
In Commercial Distribution
DUNS Number:
533708202
Device Count:
10
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
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:
07290006418111
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
17290006418118
Item #2 - Device ID Type:
Unit of Use
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 62106
Name: Multiple formulation agar culture medium IVD
Definition:
A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.
FDA Product Codes
JXA
Kit, Screening, Urine
Premarket Submissions
Submission Number:
K921045
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
15
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
25
Storage Handling - Storage Handling Type:
Storage Environment Temperature