QUUClass II

Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

21 CFR 866.3046 / Microbiology

QUU is the FDA product code for Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples, a class II device type, regulated under 21 CFR 866.3046. FDA's definition for this code reads: "A simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) is a prescription in vitro diagnostic device used to detect and presumptively identify B. anthracis and other Bacillus spp. in human clinical samples as an aid in the diagnosis of anthrax and other diseases caused...". As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2023-11-20, and no recalls.

Classification record

Product code: QUU
Device name: Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
FDA definition: A simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) is a prescription in vitro diagnostic device used to detect and presumptively identify B. anthracis and other Bacillus spp. in human clinical samples as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device is simple to use and does not involve sample manipulation or measurement of an analyte that could be affected by conditions such as sample turbidity or cell lysis. This device may be used to aid in the presumptive diagnosis of anthrax in individuals who have signs and symptoms consistent with anthrax and a likelihood of exposure. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, gastrointestinal disease, non-gastrointestinal infections, and an anthrax-like illness caused by B. cereus.
Regulation: 21 CFR 866.3046
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code QUU

By decision year

2 clearances under product code QUU with a decision year between 2023 and 2023, 2023 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code QUU by decision year
Year	Clearances
2023	2

Applicants with the most clearances

Product code QUU

Applicants holding the most 510(k) clearances under product code QUU
Applicant	Clearances
First Light Diagnostics, Inc.	1
Inbios International, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Inbios International, Inc.

Recent clearances

Product code QUU

Recent recalls

Product code QUU

FDA records show no recalls under product code QUU.

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)