QPW — Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube Class N

FDA Device Classification

FDA product code QPW covers "Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
QPW
Device Class
Class N
Regulation Number
Submission Type
Review Panel
HE
Medical Specialty
Unknown
Implant
No

Definition

A blood collection tube intended for emergency use in healthcare settings to collect, transport, and store blood specimens for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19.