Magpix®

FDA UDI

Class II (US FDA UDI)

by Luminex Corporation

Identity

Trade Name: MAGPIX® FDA UDI
Generic Name: Multiplex analyser IVD, laboratory FDA UDI
Device Name: The MAGPIX system is a multiplex test system intended to measure and sort multiple signals generated in an assay from a sample. The system includes a signal reader unit, raw data storage mechanisms, data acquisition software to process detected signals and system reagents. The MAGPIX platform is intended for use in a Clinical Diagnostic laboratory. The system will be used for protein expression and nucleic acid applications. FDA UDI
Model / Reference: MAGPIX FDA UDI
Description: The MAGPIX system is a multiplex test system intended to measure and sort multiple signals generated in an assay from a sample. The system includes a signal reader unit, raw data storage mechanisms, data acquisition software to process detected signals and system reagents. The MAGPIX platform is intended for use in a Clinical Diagnostic laboratory. The system will be used for protein expression and nucleic acid applications. FDA UDI

Identifiers

Primary DI / UDI-DI: 00840487100264 FDA UDI
510(k) Number: K121894 FDA UDI
FDA Product Code: NSU FDA UDI
GMDN Term: Multiplex analyser IVD, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.2570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiplex analyser IVD, laboratory

Magpix® by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K121894 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: Luminex Corporation

Sources (1)

FDA UDI 3f0cfd3a-1991-46c5-a345-c3f6aaf02e53 35 fields · synced Jun 9, 2026