ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY
FDA premarket approval P930036/S003 · decided 2005-10-07
Approval details
- PMA number
- P930036
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2005-07-22
- Decision date
- 2005-10-07
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ACS:180 AND THE CENTAUR AFP ASSAYS ON THE ADVIA CENTAUR CP SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR CP AFP AND IS INDICATED FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE DETERMINATION OF ALPHA-FETOPROTEIN (AFP) IN 1) HUMAN SERUM AND IN AMNIOTIC FLUID FROM SPECIMENS OBTAINED AT 15 AND 20 WEEKS GESTATION, AS AN AID IN DETECTING OPEN NEURAL TUBE DEFECTS (NTDS) WHEN USED IN CONJUNCTION WITH ULTRASONOGRAPHY AND AMNIOGRAPHY TESTING 2) HUMA
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