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

Gram-Negative Bacteria And Associated Resistance Markers

21 CFR 866.3365 / Microbiology
FDA source (opens on fda.gov)

PEN is the FDA product code for Gram-Negative Bacteria And Associated Resistance Markers, a class II device type, regulated under 21 CFR 866.3365. FDA's definition for this code reads: "A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
PEN
Device name
Gram-Negative Bacteria And Associated Resistance Markers
FDA definition
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Regulation
21 CFR 866.3365
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
12
Ingested recalls
20

Clearances, product code PEN

By decision year
12 clearances under product code PEN with a decision year between 2013 and 2026, 2019 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PEN by decision year
YearClearances
20131
20141
20151
20161
20181
20192
20201
20221
20241
20251
20261

Applicants with the most clearances

Product code PEN
Applicants holding the most 510(k) clearances under product code PEN
ApplicantClearances
BioFire Diagnostics, LLC6
Genmark Diagnostics, Incorporated2
Luminex Corporation2
Icubate, Inc.1
QIAGEN GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code