Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT02068469
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2014-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In Vitro Diagnostic Device for the Detection of Strep A
Sponsor:
IQuum, Inc.
Organization:
Study Overview
Official Title:
Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: