# Keva Inc. (manufacturer, Blaine, WA): 2 new FDA device listings, incl. test, follicle stimulating hormone (fsh), over the counter

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Keva Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Blaine, WA, US |
| New listings | 2 |
| Devices | Test, Follicle Stimulating Hormone (Fsh), Over The Counter; Test, Luteinizing Hormone (Lh), Over The Counter |
| Product codes | NGA, NGE |
| Device classes | Class I |
| Medical specialties | Clinical Chemistry |
| Brand names | HerSure FSH Test; HerSure Ovulation Test |
| First new listing | 2026-06-05 |
| Latest new listing | 2026-08-11 |
| FDA registration number | 3043196750 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.