DEVICE: ePlex System (00857167005030)

Device Identifier (DI) Information

ePlex System
ePlex Respiratory Panel (RP)
In Commercial Distribution
EA001012
GENMARK DIAGNOSTICS, INC.
00857167005030
GS1

1
962104217 *Terms of Use
ePlex Respiratory Panel Kit, 12 test, IVD
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple 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 one or multiple antigens from viruses 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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FDA Product Code

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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K163636 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

54c96299-7b9d-4627-b15a-703efee6e057
August 23, 2019
3
December 29, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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