Product code SBT— Microbiology
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- Classification name
- Device To Detect Microbial Colonization Directly From Clinical Specimens.
- Device class
- Class 2
- Regulation
- 21 CFR 866.3967
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SBT
FDA has cleared device under product code SBT, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SBT
Recent clearances under product code SBT
Data sourced from openFDA. This site is unofficial and independent of the FDA.