FDA product code SBT: Device To Detect Microbial Colonization Directly From Clinical Specimens.

SBT is the FDA product code for device to detect microbial colonization directly from clinical specimens.. It is a Class II device, regulated under 21 CFR 866.3967 and reviewed by the Microbiology panel. Devices under SBT 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 microbial colonization directly from clinical specimens is a qualitative in vitro diagnostic device intended for the detection and identification of microbial-associated targets from patients who are suspected of being colonized with a microbial pathogen and may present a risk of transmission to other patients and health care workers. This device is intended to aid in the detection of microbial colonizers for the prevention and control of infection in healthcare settings when used in conjunction with clinical and laboratory findings.

Classification

Recalls for SBT devices

openFDA lists no recalls for product code SBT.

Frequently asked questions

What is FDA product code SBT?

SBT is the FDA product code for device to detect microbial colonization directly from clinical specimens.. It is a Class II device, regulated under 21 CFR 866.3967 and reviewed by the Microbiology panel.

What device class is SBT?

Class II, regulation 21 CFR 866.3967. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code SBT
• Run a recall and safety report across every SBT manufacturer
• Watch product code SBT 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.

All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times