| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | AUTODELFIA HAFP TEST KIT |
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| Generic Name | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
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| Applicant | PerkinElmer, Inc.
940 Winter Street
Waltham, MA 02451 |
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| PMA Number | P970037 |
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| Date Received | 08/26/1997 |
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| Decision Date | 03/31/1998 |
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| Product Code |
LOK |
| Docket Number | 98M-0306 |
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| Notice Date | 05/27/1998 |
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| Advisory Committee |
Immunology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
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). |
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 |
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