Device To Detect Microbial Colonization Directly From Clinical Specimens.
SBT · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3967
Classification
FDA Product Code
SBT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3967
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.