DEVICE: ePlex System (00857167005016)

Device Identifier (DI) Information

ePlex System
ePlex Respiratory Panel (RP)
In Commercial Distribution
KT022287
GENMARK DIAGNOSTICS, INC.
00857167005016
GS1

1
962104217 *Terms of Use
Respiratory Panel Cartridge
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
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?
48425 Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis G virus in a clinical specimen, using an enzyme immunoassay (EIA) method.
Active false
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K163636 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f24cb749-b64e-414e-bbc1-feea8a9e04aa
June 22, 2023
4
January 03, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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