Immunoassay, Pregnanediol Glucuronide, Over The Counter
Clinical Chemistry · 21 CFR 862.1620
Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
17 firms currently registered for this product code
Genabio Diagnostics Inc
Bedford, MA, US
Elite Sourcing And Logistics Llc
Denver, CO, US
Assure Tech. (hangzhou) Co., Ltd.
Hangzhou Zhejiang, CN
Hangzhou Careomedic Tech Co., Ltd.
Hangzhou Zhejiang, CN
Eli Health
Montreal Quebec, CA
Quanovate Tech Inc.
San Ramon, CA, US
Hong Kong Medsourcing Limited
KOWLOON, HK
Ivd Research, Llc.
Carlsbad, CA, US
Easy Healthcare Corporation
Darien, IL, US
Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou Guangdong, CN
Assure Tech. (hangzhou) Co., Ltd.
Hangzhou Zhejiang, CN
Home Health Us Incorporated
Sarasota, FL, US
Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou Guangdong, CN
Oova, Inc.
New York, NY, US
Mfb Fertility, Inc.
Boulder, CO, US
Wondfo Usa Co., Ltd.
Bolingbrook, IL, US
Guangzhou Decheng Biotechnology Co., Ltd.
Guangzhou Guangdong, CN
510(k) clearances
1 clearances for this product code