PCI · Class II · 21 CFR 866.3990

FDA Product Code PCI: Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System

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.

Leading manufacturers include Becton, Dickinson and Company.

2
Total
2
Cleared
238d
Avg days
2022
Since

List of Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Oct 31, 2025
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
K250358
Becton, Dickinson and Company
Microbiology · 266d
Cleared Jul 28, 2022
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
K214122
Becton, Dickinson and Company
Microbiology · 210d

How to use this database

This page lists all FDA 510(k) submissions for Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System devices (product code PCI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →