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ARIES® MRSA Assay

FDA UDI

Class II (US FDA UDI)

by Luminex Corporation

Identity

Trade Name
ARIES® MRSA Assay FDA UDI
Generic Name
MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The ARIES® MRSA Assay is an integrated real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of methicillin–resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization FDA UDI
Model / Reference
50-10034 FDA UDI
Description
The ARIES® MRSA Assay is an integrated real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of methicillin–resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization FDA UDI

Identifiers

Primary DI / UDI-DI
00840487101445 FDA UDI
FDA Product Code
NQX FDA UDI
GMDN Term
MRSA nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1640 FDA UDI
Commercial Distribution
Not 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

Yes

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

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Luminex Corporation

Sources (1)

  • FDA UDI 7846cb0e-1bc2-41fc-8be2-e1a29c0b9209 36 fields · synced Jun 9, 2026