Test, Follicle Stimulating Hormone (fsh), Over The Counter
Clinical Chemistry · 21 CFR 862.1300
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Changchun Wancheng Bio-Electron Co., Ltd.Open, ClassifiedFeb 4, 2026
Menopause Test Cassette (Urine)
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 false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Z-1260-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Menopause (FSH) 2 Tests
Distribution without premarket approval/clearance.
Z-0744-2026 · View FDA record ↗
Registered firms
73 firms currently registered for this product code
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Kunming Lianen Biotechnology Co., Ltd
Kunming Yunnan, CN
Hangzhou Alltest Biotech Co.,ltd
Hangzhou Zhejiang, CN
Teco Diagnostics
ANAHEIM, CA, US
Vivosens Inc
San Francisco, CA, US
Core Technology Co., Ltd.
Changping District Beijing, CN
Elite Sourcing And Logistics Llc
Denver, CO, US
Sugentech, Inc.
Cheongju-si Chungbuk, KR
Zhejiang Orient Gene Biotech
Huzhou Zhejiang, CN
Safecare Biotech(hangzhou)co.,ltd
Huzhou Zhejiang, CN
Co-innovation Biotech Co.,ltd.
Guangzhou Guangdong, CN
Keva Inc.
Blaine, WA, US
Hong Kong Medsourcing Limited
KOWLOON, HK
Weihai Kangzhou Biotechnology Engineering Co., Ltd.
Weihai Shandong, CN
Acro Biotech Inc.
Montclair, CA, US
Huedx
Philadelphia, PA, US
Assure Tech. (hangzhou) Co., Ltd.
Hangzhou Zhejiang, CN
Changchun Lyz Technology Co.,ltd
Changchun City Jilin, CN
Qingdao Hightop Biotech Co., Ltd.
Qingdao Shandong, CN
Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou Guangdong, CN
Home Health Us Incorporated
Sarasota, FL, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Changchun Merydi Bio-tech Co., Ltd.
changchun Jilin, CN
Hangzhou Alltest Biotech Co.,ltd
Hangzhou Zhejiang, CN
510(k) clearances
2 clearances for this product code