PDS — Amniotic Fluid Protein Immunoassay Class I
FDA product code PDS covers "Amniotic Fluid Protein Immunoassay", a Class I medical device regulated under 21 CFR 862.1550. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- PDS
- Device Class
- Class I
- Regulation Number
- 862.1550
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
To detect specified amniotic fluid proteins in cervicovaginal samples