PMA P160052S001
- Device
- PartoSure Test
- Applicant
- Qiagen, Inc.
- PMA number
- P160052
- Supplement
- S001
- Product code
- QBB
- Decision date
- 2019-10-11
- Classification
- Placental Alpha Microglobulin-1 Immunoassay
- Generic name
- Placental alpha microglobulin-1 immunoassay
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol
Current openFDA PMA Record#
- Device
- PartoSure Test
- Applicant
- Qiagen, Inc.
- PMA number
- P160052
- Supplement
- S001
- Product code
- QBB
- Generic name
- Placental alpha microglobulin-1 immunoassay
- Decision date
- 2019-10-11
- Decision code
- APPR
- Date received
- 2018-05-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol