PMA P970037S010
- Device
- AutoDELFIA hAFP Test System
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S010
- Product code
- LOK
- Decision date
- 2017-06-07
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Changes being made in the hAFP antibody production: 1) use of additional L-glutamine supplement during the production of the coating antibody to the medium that contains nutrients (glucose and glutamine), and setting a recommended minimum concentration of glutamine during the production of the hAFP antibodies; and 2) addition of glutamine and glutamate testing of the routine anti-hAFP antibody production samples to the presently performed glucose and lactate testing.
Current openFDA PMA Record#
- Device
- AutoDELFIA hAFP Test System
- Applicant
- Revvity, Inc.
- PMA number
- P970037
- Supplement
- S010
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2017-06-07
- Decision code
- OK30
- Date received
- 2017-05-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes being made in the hAFP antibody production: 1) use of additional L-glutamine supplement during the production of the coating antibody to the medium that contains nutrients (glucose and glutamine), and setting a recommended minimum concentration of glutamine during the production of the hAFP antibodies; and 2) addition of glutamine and glutamate testing of the routine anti-hAFP antibody production samples to the presently performed glucose and lactate testing.