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ePlex System

FDA UDI

Class II (US FDA UDI)

by GenMark Diagnostics

Identity

Trade Name
ePlex System FDA UDI
Generic Name
Multiple-genus respiratory virus antigen IVD, kit, multiplex FDA UDI
Device Name
ePlex Respiratory Panel Kit, 12 test, IVD FDA UDI
Model / Reference
ePlex Respiratory Panel (RP) FDA UDI
Description
ePlex Respiratory Panel Kit, 12 test, IVD FDA UDI

Identifiers

Catalog Number
EA001012 FDA UDI
Primary DI / UDI-DI
00857167005030 FDA UDI
510(k) Number
K163636 FDA UDI
FDA Product Code
OZY FDA UDI
OZX FDA UDI
OZE FDA UDI
OTG FDA UDI
OQW FDA UDI
OOU FDA UDI
OEP FDA UDI
OEM FDA UDI
OCC FDA UDI
GMDN Term
Multiple-genus respiratory virus antigen IVD, kit, multiplex FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3980 FDA UDI
866.3332 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-genus respiratory virus antigen IVD, kit, multiplex

ePlex System by GenMark Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-genus respiratory virus antigen IVD, kit, multiplex.

Cleared under the same submission

K163636 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GenMark Diagnostics

Sources (1)

  • FDA UDI 54c96299-7b9d-4627-b15a-703efee6e057 35 fields · synced May 30, 2026