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

Mass Spectrometry, Microorganism Identification, Blood Culture

21 CFR 866.3378 / Microbiology
FDA source (opens on fda.gov)

QNJ is the FDA product code for Mass Spectrometry, Microorganism Identification, Blood Culture, a class II device type, regulated under 21 CFR 866.3378. FDA's definition for this code reads: "Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QNJ
Device name
Mass Spectrometry, Microorganism Identification, Blood Culture
FDA definition
Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.
Regulation
21 CFR 866.3378
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
2
Ingested recalls
0

Clearances, product code QNJ

By decision year
2 clearances under product code QNJ with a decision year between 2020 and 2024, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QNJ by decision year
YearClearances
20201
20241

Applicants with the most clearances

Product code QNJ
Applicants holding the most 510(k) clearances under product code QNJ
ApplicantClearances
Accelerate Diagnostics, Inc.1
Bruker Daltonik GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code