QIDClass II

Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

21 CFR 866.4002 / Microbiology

QID is the FDA product code for Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens, a class II device type, regulated under 21 CFR 866.4002. FDA's definition for this code reads: "A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2019-10-10, and no recalls.

Classification record

Product code: QID
Device name: Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
FDA definition: A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure. Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.
Regulation: 21 CFR 866.4002
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code QID

By decision year

1 clearance under product code QID with a decision year between 2019 and 2019, 2019 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QID by decision year
Year	Clearances
2019	1

Applicants with the most clearances

Product code QID

Applicants holding the most 510(k) clearances under product code QID
Applicant	Clearances
OraSure Technologies, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

OraSure Technologies, Inc.

Recent clearances

Product code QID

DEN190025Class IIOraQuick Ebola Rapid Antigen TestOraSure Technologies, Inc. / cleared 2019-10-10

Recent recalls

Product code QID

FDA records show no recalls under product code QID.

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)