FDA product code QPW: Reagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube

QPW is the FDA product code for reagents and transportation supplies, sodium citrate blood specimen collection tube. It is a Not classified device, reviewed by the Hematology panel. Devices under QPW reach the market by PMA; FDA lists no cleared 510(k)s for it.

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.

Classification

FieldValue
Device nameReagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection Tube
Device classNot classified
Review panelHE — Hematology
Medical specialtyUnknown
Premarket routePMA

Recalls for QPW devices

openFDA lists no recalls for product code QPW.

Frequently asked questions

What is FDA product code QPW?

QPW is the FDA product code for reagents and transportation supplies, sodium citrate blood specimen collection tube. It is a Not classified device, reviewed by the Hematology panel.

What device class is QPW?

Not classified. Typical premarket route: PMA.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All Hematology product codes · FDA product code lookup