QBGNot classified

Assay, Oral Direct Thrombin Inhibitor

Unknown

QBG is the FDA product code for Assay, Oral Direct Thrombin Inhibitor. FDA's definition for this code reads: "An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QBG
Device name: Assay, Oral Direct Thrombin Inhibitor
FDA definition: An assay used to determine the level of oral direct thrombin inhibitors (DTI) present in human plasma
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QBG

FDA records hold no clearances under product code QBG.

Recent recalls

Product code QBG

FDA records show no recalls under product code QBG.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)