PMA P930036S001
- Device
- ACS: CENTAUR AFP IMMUNOASSAY
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S001
- Product code
- LOK
- Decision date
- 1998-07-15
- Classification
- Kit, Test, Alpha-fetoprotein For Neural Tube Defects
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Approval order statement
- Approval to add the existing AFP assay performed on the ACS:180 to a new generation of instrumentation, the Centaur and is indicated for the quantitative determination of alpha-fetoprotein (AFP) in the following:human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, as an aid in detecting open neura tube defects (NTDs) when used in conjucntion with ultrasonography and amniography testing, using the Chiron Diagnostics ACS:Centaur(TM) Automated Chemiluminescence System.
Current openFDA PMA Record#
- Device
- ACS: CENTAUR AFP IMMUNOASSAY
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S001
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 1998-07-15
- Decision code
- APPR
- Date received
- 1998-05-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to add the existing AFP assay performed on the ACS:180 to a new generation of instrumentation, the Centaur and is indicated for the quantitative determination of alpha-fetoprotein (AFP) in the following:human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, as an aid in detecting open neura tube defects (NTDs) when used in conjucntion with ultrasonography and amniography testing, using the Chiron Diagnostics ACS:Centaur(TM) Automated Chemiluminescence System.