Test System, Nicotine, Cotinine, Metabolites
The Nicotine, Cotinine, and Metabolites Test System is a clinical toxicology in vitro diagnostic device used to detect and measure nicotine and its metabolites (primarily cotinine) in biological samples, used for assessing tobacco use, nicotine replacement therapy monitoring, or workplace testing. Classified as FDA Class 1 under 21 CFR 862.3220 in the Clinical Toxicology specialty, it is 510(k)-exempt and subject only to general controls. The product code is MRS.
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Basic Information
- Product Code
- MRS
- Device Class
- FDA class 1
- Regulation Number
- 862.3220
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.