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

Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

21 CFR 866.3183 / Microbiology
FDA source (opens on fda.gov)

QLX is the FDA product code for Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna, a class II device type, regulated under 21 CFR 866.3183. FDA's definition for this code reads: "A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QLX
Device name
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
FDA definition
A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant patients with active viral infection or at risk for developing viral infections. The test results are intended to be interpreted by qualified healthcare professionals in conjunction with other relevant clinical and laboratory findings.
Regulation
21 CFR 866.3183
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
4
Ingested recalls
0

Clearances, product code QLX

By decision year
4 clearances under product code QLX with a decision year between 2020 and 2025, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QLX by decision year
YearClearances
20201
20211
20221
20251

Applicants with the most clearances

Product code QLX
Applicants holding the most 510(k) clearances under product code QLX
ApplicantClearances
Abbott Molecular, Inc.2
Roche Molecular Systems Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code