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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSALEST TM SYSTEM
Classification Namesalivary estriol test
ApplicantHOLOGIC, INC.
PMA NumberP970032
Date Received07/16/1997
Decision Date04/29/1998
Product Code
PEJ
Docket Number 99M-2168
Notice Date 07/13/1999
Advisory Committee Clinical Chemistry
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the salest(tm). This device is intended to detect and measure by enzyme-linked immunoabsorbant assay (elisa) technology the level of salivary estriol in pregnant women. The device is indicated for use as an aid in identifying risk of spontaneous preterm labor and delivery in singleton pregnancies. The device can be used every 1 to 2 weeks from gestational ages 22 to 36 weeks. The test should be used as a component of the clinician's assessment of risk for preterm labor and delivery.
Approval Order Approval Order
Supplements: S001 
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