PMA P120008S008
- Device
- ARCHITECT AFP ASSAY (LN 3P36)
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S008
- Product code
- LOK
- Decision date
- 2015-07-13
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- CHANGE TO THE SUPPLIER OF BOVINE SERUM ALBUMIN (BSA) FOR USE INTHE MANUFACTURE OF PRECURSOR COMPONENTS FOR THE ARCHITECT HBSAG QUALITATIVE (LN 4P53),ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54), AND ARCHITECT AFP (LN 3P36) ASSAYS.
Current openFDA PMA Record#
- Device
- ARCHITECT AFP ASSAY (LN 3P36)
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S008
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2015-07-13
- Decision code
- OK30
- Date received
- 2015-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SUPPLIER OF BOVINE SERUM ALBUMIN (BSA) FOR USE INTHE MANUFACTURE OF PRECURSOR COMPONENTS FOR THE ARCHITECT HBSAG QUALITATIVE (LN 4P53),ARCHITECT HBSAG QUALITATIVE CONFIRMATORY (LN 4P54), AND ARCHITECT AFP (LN 3P36) ASSAYS.