QZG — Menstrual Blood Collection Device Class II

FDA Device Classification

FDA product code QZG covers "Menstrual Blood Collection Device", a Class II medical device regulated under 21 CFR 862.1675. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
QZG
Device Class
Class II
Regulation Number
862.1675
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Definition

Intended to collect and transport menstrual blood specimens to the laboratory for in vitro diagnostic testing