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ARIES® Group A Strep Assay

FDA UDI

Class II (US FDA UDI)

by Luminex Corporation

Identity

Trade Name
ARIES® Group A Strep Assay FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis. FDA UDI
Model / Reference
50-10041 FDA UDI
Description
The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis. FDA UDI

Identifiers

Primary DI / UDI-DI
00840487101469 FDA UDI
FDA Product Code
PGX FDA UDI
OOI FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.2680 FDA UDI
862.2570 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® Group A Strep 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 dc5c6754-e593-4f7a-812b-9d604ef7b7e6 36 fields · synced Jun 9, 2026