Luminex Molecular Diagnostics Inc
TORONTO Ontario, CA
LUMINEX MOLECULAR DIAGNOSTICS, INC. appears in FDA device records in TORONTO Ontario, CA. FDA records list 26 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Luminex Molecular Diagnostics Inc between 2008 and 2024. The busiest year on record is 2013, with 4. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 3 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen Panel | OCC | Substantially Equivalent | |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) | QOF | Substantially Equivalent | |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | OCC | Substantially Equivalent | |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | PCH | Substantially Equivalent | |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | PCH | Substantially Equivalent | |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | PCH | Substantially Equivalent | |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | PCH | Substantially Equivalent | |
| K170492 | xTAG CYP2D6 Kit v3 | NTI | Substantially Equivalent | |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | NUA | Unknown | |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | NUA | Unknown | |
| K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | OCC | Substantially Equivalent | |
| K140647 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) | PCH | Substantially Equivalent | |
| K140377 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) | PCH | Substantially Equivalent | |
| K131565 | XTAG CYP2C19 KIT V3 | NTI | Substantially Equivalent | |
| K130189 | XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) | NTI | Substantially Equivalent | |
| K121894 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX | PCH | Substantially Equivalent | |
| DEN130003 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) | PCH | Unknown | |
| K112781 | TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) | OCC | Substantially Equivalent | |
| K112199 | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) | OCC | Substantially Equivalent | |
| K103776 | XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST | OCC | Substantially Equivalent | |
| K093420 | XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) | NTI | Substantially Equivalent | |
| K083845 | XTAG CF60 KIT V2 | NUA | Substantially Equivalent | |
| K083846 | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 | NUA | Substantially Equivalent | |
| K091667 | XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 | OCC | Substantially Equivalent | |
| K081483 | XTAG RESPIRATORY VIRAL PANEL | OCC | Substantially Equivalent | |
| DEN070013 | ID-TAG RESPIRATORY VIRAL PANEL | OCC | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002777243 | 3002777243 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | 439 UNIVERSITY AVE., TORONTO Ontario M5G 1Y8 CA | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OZYChlamydophila Pneumoniae Dna Assay System
- JJHClinical Sample Concentrator
- NTIDrug Metabolizing Enzyme Genotyping Systems
- PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- PPMGeneral Purpose Reagent
- OEMHuman Metapneumovirus (Hmpv) Rna Assay System
- OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay
- NSUInstrumentation For Clinical Multiplex Test Systems
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- OZXMycoplasma Pneumoniae Dna Assay System
- OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay
- NXDNucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
- OOUParainfluenza Multiplex Nucleic Acid Assay
- OOIReal Time Nucleic Acid Amplification System
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0043-2025 | NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468 | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives. | Class II | Open, Classified | |
| Z-0042-2025 | NxTAG Respiratory Pathogen Panel, REF: I051C0447 | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives. | Class II | Open, Classified | |
| Z-0161-2020 | xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test | The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims. | Class II | Open, Classified | |
| Z-1767-2019 | xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316. | Reports have been received of lower MS2 MFI values when using the panel. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain