Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-07-21 @ 3:57 AM
Study NCT ID:
NCT03251261
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2017-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Cytomegalovirus Virus in Neonates
Sponsor:
Meridian Bioscience, Inc.
Organization:
Study Overview
Official Title:
Illumigene CMV Clinical Trial Protocol
Status:
COMPLETED
Status Verified Date:
2019-01
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:
CMV
Brief Summary:
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: