Product code PCI— Microbiology
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
- Classification name
- Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
- Device class
- Class 2
- Regulation
- 21 CFR 866.3990
- Advisory panel
- Microbiology
- Total cleared
- 5
- First cleared
- Most recent
FDA classification definition
“A gastrointestinal bacterial panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal bacterial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal bacterial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings.”
Market context for product code PCI
FDA has cleared devices under product code PCI between 2014 and 2025, filed by 3 applicant companies. 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.
Clearances per year
- 2025
- 2022
- 2018
- 2017
- 2014
Top applicants under product code PCI
Recent clearances under product code PCI
- K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
- K214122 — BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
- K173330 — PanNAT STEC Test
- K163571 — Great Basin Stool Bacterial Pathogens Panel
- K140111 — BD MAX(TM) ENTERIC BACTERIAL PANEL; BD MAX(TM) INSTRUMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.