Test, Cocaine And Cocaine Metabolites, Over The Counter
The Test, Cocaine And Cocaine Metabolites, Over The Counter (product code NFY) is an in vitro diagnostic test designed for consumer use to detect cocaine and its metabolites in urine specimens for home-based drug screening. It is classified as an FDA Class 2 device within the Clinical Toxicology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NFY
- Device Class
- FDA class 2
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.