DEVICE: ePlex System (00857167005023)
Device Identifier (DI) Information
ePlex System
ePlex Respiratory Panel (RP)
In Commercial Distribution
KT022006
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution
KT022006
GENMARK DIAGNOSTICS, INC.
ePlex Sample Delivery Device RP Panel
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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48245 | Multiple-genus respiratory virus antigen IVD, kit, multiplex |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen, using a multiplex method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OZY | Chlamydophila Pneumoniae Dna Assay System |
OZX | Mycoplasma Pneumoniae Dna Assay System |
OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
OTG | Non-Sars Coronavirus Multiplex Nucleic Acid Assay |
OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
OOU | Parainfluenza Multiplex Nucleic Acid Assay |
OEP | Influenza A Virus Subtype Differentiation Nucleic Acid Assay |
OEM | Human Metapneumovirus (Hmpv) Rna Assay System |
OCC | Respiratory Virus Panel Nucleic Acid Assay System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K163636 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7524d466-13b9-43a8-a822-717239fba8eb
December 18, 2023
5
January 03, 2018
December 18, 2023
5
January 03, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined