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QZXClass II

Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

21 CFR 866.1650 / Microbiology
FDA source (opens on fda.gov)

QZX is the FDA product code for Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing, a class II device type, regulated under 21 CFR 866.1650. FDA's definition for this code reads: "Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QZX
Device name
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
FDA definition
Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.
Regulation
21 CFR 866.1650
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
3
Ingested recalls
0

Clearances, product code QZX

By decision year
3 clearances under product code QZX with a decision year between 2024 and 2025, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QZX by decision year
YearClearances
20242
20251

Applicants with the most clearances

Product code QZX
Applicants holding the most 510(k) clearances under product code QZX
ApplicantClearances
Selux Diagnostics, Inc.2
Avails Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code