Test, Morphine, Over The Counter
The Test, Morphine, Over The Counter (product code NGI) is an in vitro diagnostic test for consumer home use that detects morphine or morphine metabolites in urine, used for drug screening purposes. 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
- NGI
- Device Class
- FDA class 2
- Regulation Number
- 862.3640
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.