Container, Specimen, Urine, Drugs Of Abuse, Over The Counter
The Urine Specimen Container for Over-the-Counter Drugs of Abuse Testing is a pathology device used by consumers to collect urine samples for the purpose of testing for drugs of abuse using over-the-counter test kits. Classified as FDA Class 1 under 21 CFR 864.3260 in the Pathology specialty, it is 510(k)-exempt and subject only to general controls. The product code is MPQ.
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Basic Information
- Product Code
- MPQ
- Device Class
- FDA class 1
- Regulation Number
- 864.3260
- Medical Specialty
- Pathology
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.