Product Code: NFV FDA class 2 21 CFR 862.3170

Test, Benzodiazepine, Over The Counter

Clinical Toxicology

The Test, Benzodiazepine, Over The Counter (product code NFV) is an in vitro diagnostic test designed for consumer use to detect benzodiazepines in urine, enabling home-based drug screening for substances such as diazepam, alprazolam, or lorazepam. 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.

510(k)s
0
FEI Numbers
48
Registration Numbers
48
Unique Applicants
0
Years Active

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Basic Information

Product Code
NFV
Device Class
FDA class 2
Regulation Number
862.3170
Medical Specialty
Clinical Toxicology
Review Panel
TX
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

FEI Numbers

This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.