FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Salivary Estriol Test
PMA: P970032
·
Decision Apr 29, 1998
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Salivary Estriol Test
- Trade Name
- SALEST TM SYSTEM
- PMA Number
- P970032
- Device Class
- FDA Class 3
- Product Code
- PEJ
- Generic Name
- salivary estriol test
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- April 29, 1998
- Date Received
- July 16, 1997
- Expedited Review
- Y
- Docket Number
- 99M-2168
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PEJ | Salivary Estriol Test | FDA class 3 | Unknown |