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

System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

21 CFR 866.1640 / Microbiology
FDA source (opens on fda.gov)

NQX is the FDA product code for System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, a class II device type, regulated under 21 CFR 866.1640. FDA's definition for this code reads: "A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings". As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
NQX
Device name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
FDA definition
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
Regulation
21 CFR 866.1640
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
24
Ingested recalls
20

Clearances, product code NQX

By decision year
24 clearances under product code NQX with a decision year between 2004 and 2024, 2013 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NQX by decision year
YearClearances
20042
20072
20082
20091
20103
20112
20122
20134
20141
20161
20192
20242

Applicants with the most clearances

Product code NQX
Applicants holding the most 510(k) clearances under product code NQX
ApplicantClearances
Cepheid10
BD Diagnostics (Geneohm Sciences Canada, Inc)2
Infectio Diagnostic (I.D.I.), Inc.2
Luminex Corporation2
Roche Molecular Systems Inc2
BD Diagnostics (Geneohm Sciences, Inc.)1
Elitech1
Elitechgroup Epoch Biosciences1
Geneohm Sciences Canada, Inc.1
Geneohm Sciences Canada, Inc. (BD Diagnostics)1

Companies listing this code with FDA

Companies whose registered establishments list this code