Test, Follicle Stimulating Hormone (Fsh), Over The Counter
The Test, Follicle Stimulating Hormone (FSH), Over The Counter (product code NGA) is an in vitro diagnostic test for consumer use that measures FSH levels in urine, used to help women assess whether they may be approaching menopause or experiencing a fertility-related hormonal change. It is classified as an FDA Class 1 device within the Clinical Chemistry specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. 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
- NGA
- Device Class
- FDA class 1
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 66 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 66 registration numbers. Click on an entry to view related FDA registrations.