FDA product code QHV: Multiple Osteoarticular Pathogen Antigen Kit

QHV is the FDA product code for multiple osteoarticular pathogen antigen kit. It is a Not classified device, reviewed by the Microbiology panel. Devices under QHV reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.

Definition

Qualitative detection of microbial antigen in synovial fluid

Classification

FieldValue
Device nameMultiple Osteoarticular Pathogen Antigen Kit
Device classNot classified
Review panelMI — Microbiology
Medical specialtyUnknown
Premarket routeContact FDA

Recalls for QHV devices

openFDA lists no recalls for product code QHV.

Frequently asked questions

What is FDA product code QHV?

QHV is the FDA product code for multiple osteoarticular pathogen antigen kit. It is a Not classified device, reviewed by the Microbiology panel.

What device class is QHV?

Not classified. Typical premarket route: Contact FDA.

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.

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