The device is intended for the quantitative determination of human alpha-fetoprotein (afp) in maternal serum and amniotic fluid obtained between the 15th and 21st weeks of gestation. The assay is to be peformed on the 1235 autodelfia(tm) automatic immunoassay system, and is intended for use only in conjunction with other diagnostic tools such as ultrasound and amniography as an aid in the detection of open neural tube defects (ontds).
| Device | AUTODELFIA HAFP TEST KIT |
| Classification Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Generic Name | Kit, Test, Alpha-fetoprotein For Neural Tube Defects |
| Applicant | PerkinElmer, Inc. |
| Date Received | 1997-08-26 |
| Decision Date | 1998-03-31 |
| Notice Date | 1998-05-27 |
| PMA | P970037 |
| Supplement | S |
| Product Code | LOK |
| Docket Number | 98M-0306 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PerkinElmer, Inc. 940 Winter Street waltham, MA 02451 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970037 | | Original Filing |
| S012 |
2021-07-15 |
30-day Notice |
| S011 |
2018-08-09 |
30-day Notice |
| S010 |
2017-05-11 |
30-day Notice |
| S009 |
2016-07-27 |
30-day Notice |
| S008 |
2012-05-15 |
30-day Notice |
| S007 |
2011-09-23 |
135 Review Track For 30-day Notice |
| S006 |
2011-06-13 |
30-day Notice |
| S005 |
2011-03-17 |
30-day Notice |
| S004 |
2011-02-02 |
30-day Notice |
| S003 |
2010-03-01 |
Normal 180 Day Track |
| S002 |
2008-09-17 |
Normal 180 Day Track |
| S001 |
2002-10-18 |
Special (immediate Track) |
NIH GUDID Devices