PMA P120008S003
- Device
- ARCHITECT AFP,LN 3P36
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S003
- Product code
- LOK
- Decision date
- 2013-06-12
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- CHANGE FOR THE ADDITION OF A QUALITY CONTROL TEST FOR PROTEIN PURITY OF INCOMING RAW MATERIAL (ALBUMIN BOVINE 30% SOLUTION WITH 0.1% SODIUM AZIDE (BOVINE ALBUMIN SOLUTION) USED IN THE MANUFACTURING OF CONTROLS AND CALIBRATORS FOR THE ARCHITECT AFP ASSAY. DUE TO THE RAW MATERIAL DISTRIBUTOR NOT HAVING A VALIDATED QUALITY CONTROL TEST FOR PROTEIN PURITY, THE ADDITIONAL QUALITY CONTROL TEST WILL BE IMPLEMENTED TO ENSURE THE PROTEIN PURITY OF THE RAW MATERIAL MEETS THE MANUFACTURERS SPECIFICATIONS.
Current openFDA PMA Record#
- Device
- ARCHITECT AFP,LN 3P36
- Applicant
- Abbott Laboratories
- PMA number
- P120008
- Supplement
- S003
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2013-06-12
- Decision code
- OK30
- Date received
- 2013-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FOR THE ADDITION OF A QUALITY CONTROL TEST FOR PROTEIN PURITY OF INCOMING RAW MATERIAL (ALBUMIN BOVINE 30% SOLUTION WITH 0.1% SODIUM AZIDE (BOVINE ALBUMIN SOLUTION) USED IN THE MANUFACTURING OF CONTROLS AND CALIBRATORS FOR THE ARCHITECT AFP ASSAY. DUE TO THE RAW MATERIAL DISTRIBUTOR NOT HAVING A VALIDATED QUALITY CONTROL TEST FOR PROTEIN PURITY, THE ADDITIONAL QUALITY CONTROL TEST WILL BE IMPLEMENTED TO ENSURE THE PROTEIN PURITY OF THE RAW MATERIAL MEETS THE MANUFACTURERS SPECIFICATIONS.