QTUNot classified

Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests

Unknown

QTU is the FDA product code for Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests. FDA's definition for this code reads: "Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QTU
Device name: Reagents, Non-Variola Orthopoxvirus Or Monkeypox Virus Singleplex Antigen Tests
FDA definition: Antigen-based in vitro diagnostic devices for the detection of non-variola Orthopoxvirus or monkeypox virus and/or diagnosis of Monkeypox in human clinical specimens-EXPORT ONLY
Device class: Not classified
Review panel: Unknown
Submission type: FDA code 7
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

Access Bio, Inc.

Recent clearances

Product code QTU

FDA records hold no clearances under product code QTU.

Recent recalls

Product code QTU

FDA records show no recalls under product code QTU.

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)