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 Gram Positive (GP) Panel Cartridge Pouch FDA UDI
- Model / Reference
- BCID-GP Cartridge Pouch FDA UDI
- Description
- ePlex Blood Culture Identification Gram Positive (GP) Panel Cartridge Pouch FDA UDI
Identifiers
- Catalog Number
- KT021791 FDA UDI
- Primary DI / UDI-DI
- 00857167005337 FDA UDI
- 510(k) Number
- K181663 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.
- iC-GPC Assay — Icubate, Inc. · Class II
- Accelerate PhenoTest® BC kit — Accelerate Diagnostics, Inc. · Class II
- Accelerate PhenoTest BC kit — Accelerate Diagnostics, Inc. · Class II
- 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
K181663 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GenMark Diagnostics
Sources (1)
- FDA UDI f9210718-3d10-47ed-ab9b-e8bc71692f65 35 fields · synced Jun 1, 2026