← Back to catalogue

LIAISON PLEX Gram-Negative Blood Culture Assay

FDA UDI

Class II (US FDA UDI)

by Luminex Corporation

Identity

Trade Name
LIAISON PLEX Gram-Negative Blood Culture Assay FDA UDI
Generic Name
Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The LIAISON PLEX® Gram-Negative Blood Culture (BCN) Assay, performed using the automated, sample-to-result LIAISON PLEX® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles. FDA UDI
Model / Reference
20-005-303 FDA UDI
Description
The LIAISON PLEX® Gram-Negative Blood Culture (BCN) Assay, performed using the automated, sample-to-result LIAISON PLEX® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles. FDA UDI

Identifiers

Catalog Number
20-005-303 FDA UDI
Primary DI / UDI-DI
00840487101841 FDA UDI
510(k) Number
K243013 FDA UDI
FDA Product Code
NSU FDA UDI
PEN 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
862.2570 FDA UDI
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 Gram-Negative Blood Culture Assay 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).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Luminex Corporation

Sources (1)

  • FDA UDI 54339781-cbea-4ac1-b954-55fcdf564b9b 37 fields · synced Jun 9, 2026