Rapid Response
BTNX Inc · Model FSH-1C25 · UDI-DI 10722066005337
NGA
Prescription
2
510(k) clearances
0
Adverse events
2
Recalls
70
Facilities
Description
Rapid Response FSH Menopause Test Cassette (Urine) - 25 tests/ kit for the qualitative detection of Follicle-stimulating hormone in urine.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.