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SBTClass II

Device To Detect Microbial Colonization Directly From Clinical Specimens.

21 CFR 866.3967 / Microbiology
FDA source (opens on fda.gov)

SBT is the FDA product code for Device To Detect Microbial Colonization Directly From Clinical Specimens., a class II device type, regulated under 21 CFR 866.3967. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SBT
Device name
Device To Detect Microbial Colonization Directly From Clinical Specimens.
FDA 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.
Regulation
21 CFR 866.3967
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
1
Ingested recalls
0

Clearances, product code SBT

By decision year
1 clearance under product code SBT with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SBT by decision year
YearClearances
20241

Applicants with the most clearances

Product code SBT
Applicants holding the most 510(k) clearances under product code SBT
ApplicantClearances
DiaSorin Molecular LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code