PMA P930036S002
- Device
- ACS:180/ADVIA CENTAUR AFP IMMUNOASSAY
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S002
- Product code
- LOK
- Decision date
- 2002-02-12
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- APPROVAL FOR THE USE OF PURIFIED MOUSE AFP CLONE ML355-7G12.2A6.5C4 ANTIBODY IN THE PRODUCTION OF THE BAYER ACS:180 AND ADVIA CENTAUR AFP SOLID PHASE.
Current openFDA PMA Record#
- Device
- ACS:180/ADVIA CENTAUR AFP IMMUNOASSAY
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S002
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2002-02-12
- Decision code
- APPR
- Date received
- 2002-01-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE USE OF PURIFIED MOUSE AFP CLONE ML355-7G12.2A6.5C4 ANTIBODY IN THE PRODUCTION OF THE BAYER ACS:180 AND ADVIA CENTAUR AFP SOLID PHASE.