Product code MRS— Clinical Toxicology
DRI COTININE EIA ASSAY
- Classification name
- Test System, Nicotine, Cotinine, Metabolites
- Device class
- Class 1
- Regulation
- 21 CFR 862.3220
- Advisory panel
- Clinical Toxicology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code MRS
FDA has cleared devices under product code MRS between 1996 and 2003, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2003
- 2002
- 1996
Top applicants under product code MRS
Recent clearances under product code MRS
Data sourced from openFDA. This site is unofficial and independent of the FDA.