FDA product code QID: Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens

QID is the FDA product code for device to detect antigens of biothreat microbial agents in human clinical specimens. It is a Class II device, regulated under 21 CFR 866.4002 and reviewed by the Microbiology panel. Devices under QID reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for QID devices

openFDA lists no recalls for product code QID.

Frequently asked questions

What is FDA product code QID?

QID is the FDA product code for device to detect antigens of biothreat microbial agents in human clinical specimens. It is a Class II device, regulated under 21 CFR 866.4002 and reviewed by the Microbiology panel.

What device class is QID?

Class II, regulation 21 CFR 866.4002. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QID
• Run a recall and safety report across every QID manufacturer
• Watch product code QID for new clearances and recalls

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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