Identity
- Trade Name
- LIAISON PLEX Yeast Blood Culture Assay Kit FDA UDI
- Generic Name
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The LIAISON PLEX® Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX® System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. FDA UDI
- Model / Reference
- 20-005-306 FDA UDI
- Description
- The LIAISON PLEX® Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX® System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. FDA UDI
Identifiers
- Catalog Number
- 20-005-306 FDA UDI
- Primary DI / UDI-DI
- 00840487101865 FDA UDI
- 510(k) Number
- K240627 FDA UDI
- FDA Product Code
- PEO FDA UDI
- GMDN Term
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) 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
Category: Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
LIAISON PLEX Yeast Blood Culture Assay Kit by Luminex Corporation — 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 technique (NAT).
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- Gram-Positive Blood Culture (BC-GP) Utility Tray — Luminex Corporation · Class II
- LIAISON PLEX Gram-Negative Blood Culture Assay — Luminex Corporation · Class II
- Gram-Negative Blood Culture (BC-GN) Utility Tray — Luminex Corporation · Class II
- LIAISON PLEX Gram-Positive Blood Culture Assay — Luminex Corporation · Class II
- Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge — Luminex Corporation · Class II
- Gram-Negative Blood Culture (BC-GN) Extraction Tray — Luminex Corporation · Class II
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
- Luminex Corporation
Sources (1)
- FDA UDI b9fdcdff-62e8-49f5-a5c5-bdde51fe98f7 37 fields · synced Jun 9, 2026