FDA product code QTY: Von Willebrand Factor Assay

QTY is the FDA product code for von willebrand factor assay. It is a Class II device, regulated under 21 CFR 864.7293 and reviewed by the Hematology panel. Devices under QTY reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

A von Willebrand factor assay is a prescription device intended for the measurement of von Willebrand factor activity or von Willebrand factor size distribution in human plasma.

Classification

Recalls for QTY devices

openFDA lists no recalls for product code QTY.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• J7214 — Injection, factor viii/von willebrand factor complex, recombinant (altuviiio), per factor viii i.u.
• J7187 — Injection, von willebrand factor complex (humate-p), per iu vwf:rco
• J7186 — Injection, antihemophilic factor viii/von willebrand factor complex (human), per factor viii i.u.
• J7179 — Injection, von willebrand factor (recombinant), (vonvendi), 1 i.u. vwf:rco
• J7183 — Injection, von willebrand factor complex (human), wilate, 1 i.u. vwf:rco

Frequently asked questions

What is FDA product code QTY?

QTY is the FDA product code for von willebrand factor assay. It is a Class II device, regulated under 21 CFR 864.7293 and reviewed by the Hematology panel.

What device class is QTY?

Class II, regulation 21 CFR 864.7293. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QTY
• Run a recall and safety report across every QTY manufacturer
• Watch product code QTY for new clearances and recalls

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.

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