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

Lower Respiratory Microbial Nucleic Acid Detection System

21 CFR 866.3985 / Microbiology
FDA source (opens on fda.gov)

QBH is the FDA product code for Lower Respiratory Microbial Nucleic Acid Detection System, a class II device type, regulated under 21 CFR 866.3985. FDA's definition for this code reads: "Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
QBH
Device name
Lower Respiratory Microbial Nucleic Acid Detection System
FDA definition
Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Regulation
21 CFR 866.3985
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
4

Clearances, product code QBH

By decision year
2 clearances under product code QBH with a decision year between 2018 and 2019, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QBH by decision year
YearClearances
20181
20191

Applicants with the most clearances

Product code QBH
Applicants holding the most 510(k) clearances under product code QBH
ApplicantClearances
Curetis GmbH2

Companies listing this code with FDA

Companies whose registered establishments list this code