PMA P970037
- Device
- AutoDELFIA hAFP Test System
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S012
- Product code
- LOK
- Decision date
- 2021-08-11
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Adding the WAVE25 system and the Cogent M1 TFF system to the in vitro manufacturing of antibodies.
Current openFDA PMA Record#
- Device
- AutoDELFIA hAFP Test System
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S012
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2021-08-11
- Decision code
- OK30
- Date received
- 2021-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding the WAVE25 system and the Cogent M1 TFF system to the in vitro manufacturing of antibodies.