Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03131388
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2017-04-17
Brief Title:
Clinical Performance Evaluation of AMH Assay
Sponsor:
Beckman Coulter Inc
Organization:
Beckman Coulter Inc
Study Overview
Official Title:
Clinical Performance Evaluation of AMH Assay
Status:
COMPLETED
Status Verified Date:
2018-07
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 Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility assessment The purpose of the study is to evaluate the clinical performance of the Access AMH Assay in the intended use population
Detailed Description:
same as brief summary
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None