DeviceClearance

Product code QDH— Clinical Chemistry

picoAMH ELISA

Classification name
Menopause Test System
Device class
Class 2
Regulation
21 CFR 862.1093
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

FDA classification definition

“A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women.”

— U.S. Food and Drug Administration, device classification record for product code QDH under 21 CFR 862.1093, via openFDA

Market context for product code QDH

FDA has cleared 1 device under product code QDH, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QDH

Recent clearances under product code QDH

Data sourced from openFDA. This site is unofficial and independent of the FDA.