510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PCIClass II

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

21 CFR 866.3990 / Microbiology
FDA source (opens on fda.gov)

PCI is the FDA product code for Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System, a class II device type, regulated under 21 CFR 866.3990. FDA's definition for this code reads: "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...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PCI
Device name
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
FDA 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.
Regulation
21 CFR 866.3990
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
5
Ingested recalls
0

Clearances, product code PCI

By decision year
5 clearances under product code PCI with a decision year between 2014 and 2025, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PCI by decision year
YearClearances
20141
20171
20181
20221
20251

Applicants with the most clearances

Product code PCI
Applicants holding the most 510(k) clearances under product code PCI
ApplicantClearances
Becton Dickinson & Co3
Great Basin Scientific, Inc.1
Micronics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code