← FDA Medical Device Classifications
Amniotic Fluid Protein Immunoassay
PDS · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.1550
Classification
- FDA Product Code
PDS- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 862.1550
- Review panel
- CH
- Medical specialty
- Clinical Chemistry
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
To detect specified amniotic fluid proteins in cervicovaginal samples
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown