ACS: CENTAUR AFP IMMUNOASSAY
FDA premarket approval P930036/S001 · decided 1998-07-15
Approval details
- PMA number
- P930036
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS: CENTAUR AFP IMMUNOASSAY
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 1998-05-01
- Decision date
- 1998-07-15
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- 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 Sys
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