Identity
- Trade Name
- ePlex System FDA UDI
- Generic Name
- Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Respiratory Panel Cartridge FDA UDI
- Model / Reference
- ePlex Respiratory Panel (RP) FDA UDI
- Description
- Respiratory Panel Cartridge FDA UDI
Identifiers
- Catalog Number
- KT022287 FDA UDI
- Primary DI / UDI-DI
- 00857167005016 FDA UDI
- 510(k) Number
- K163636 FDA UDI
- FDA Product Code
- OZY FDA UDIOZX FDA UDIOZE FDA UDIOTG FDA UDIOQW FDA UDIOOU FDA UDIOEP FDA UDIOEM FDA UDIOCC FDA UDI
- GMDN Term
- Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3980 FDA UDI866.3332 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: Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
ePlex System by GenMark Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K163636 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- GenMark Diagnostics
Sources (1)
- FDA UDI f24cb749-b64e-414e-bbc1-feea8a9e04aa 35 fields · synced May 30, 2026