Early Detect, Inc.
Country not established
- Devices
- 1
What Early Detect, Inc. makes
Early Detect, Inc. manufactures the EarlyDetect Menopause Test for FSH, a diagnostic device designed to measure follicle-stimulating hormone (FSH) levels in blood plasma to aid in assessing menopausal status.
The company’s portfolio is regulated under FDA’s Class I device classification and is listed via the 510(k) premarket notification process. The manufacturer is based in the United States.
Catalogue
Earlydetect Menopause Test For Fsh Ref K030058
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Early Detect, Inc. have in the registry?
The registry currently lists 1 device for Early Detect, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Early Detect, Inc.'s devices?
Among its 1 most recently registered device, Early Detect, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Early Detect, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Early Detect, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Early Detect, Inc. in the registry?
The most recently registered devices listed for Early Detect, Inc. include EARLYDETECT MENOPAUSE TEST FOR FSH.