← FDA Medical Device Classifications
Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
PJD · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1675
Classification
- FDA Product Code
PJD- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 862.1675
- Review panel
- CH
- Medical specialty
- Clinical Chemistry
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Market data
- Cleared 510(k) submissions
- 9
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown