Identity
- Trade Name
- ePlex FDA UDI
- Generic Name
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry FDA UDI
- Device Name
- ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box FDA UDI
- Model / Reference
- BCID-FP 12 Kit Box FDA UDI
- Description
- ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box FDA UDI
Identifiers
- Catalog Number
- EA005012 FDA UDI
- Primary DI / UDI-DI
- 00857167005290 FDA UDI
- 510(k) Number
- K182690 FDA UDI
- FDA Product Code
- PEO FDA UDIPEN FDA UDIPAM FDA UDI
- GMDN Term
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3365 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
No
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
ePlex by GenMark Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry.
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- BioFire® Blood Culture Identification 2 (BCID2) Panel — BioFire Diagnostics, LLC · Class II
- Accelerate PhenoTest™ BC Kit — Accelerate Diagnostics, Inc. · Class II
- Accelerate Pheno™ System — Accelerate Diagnostics, Inc. · Class II
- Accelerate Pheno™ System — Accelerate Diagnostics, Inc. · Class II
- BioFire® Blood Culture Identification 2 (BCID2) Panel — BioFire Diagnostics, LLC · Class II
Cleared under the same submission
K182690 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 075629d0-1f29-4c39-80a7-8515b3f57f0a 35 fields · synced May 30, 2026