PMA P930036S003
- Device
- ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S003
- Product code
- LOK
- Decision date
- 2005-10-07
- 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 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) HUMAN SERUM, AS AN AID IN MANAGING NON-SEMINOMATOUS TESTICULAR CANCER WHEN USED IN CONJUNCTION WITH PHYSICAL EXAMINATION, HISTOLOGY/PATHOLOGY, AND OTHER CLINICAL EVALUATION PROCEDURES, USING THE (BAYER) SYSTEM.
Current openFDA PMA Record#
- Device
- ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- PMA number
- P930036
- Supplement
- S003
- Product code
- LOK
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Decision date
- 2005-10-07
- Decision code
- APPR
- Date received
- 2005-07-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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) HUMAN SERUM, AS AN AID IN MANAGING NON-SEMINOMATOUS TESTICULAR CANCER WHEN USED IN CONJUNCTION WITH PHYSICAL EXAMINATION, HISTOLOGY/PATHOLOGY, AND OTHER CLINICAL EVALUATION PROCEDURES, USING THE (BAYER) SYSTEM.