What is FDA product code OOU?

A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings.

Lyra · Parainfluenza Multiplex Nucleic Acid Assay → Immunology & Microbiology

Name: Lyra
Brand: Lyra

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OOU
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for Lyra
Listed by	Quidel Corp., United States
FDA product code	OOU
Device type	Parainfluenza Multiplex Nucleic Acid Assay
Device class	Class 2
Regulation	21 CFR 866.3980
Establishment	Complaint-file establishment, Manufacturer, Exporter
Record published	2016-09-15
Record revised	2025-05-23 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Lyra
Catalogue number	Size	Status
Parainfluenza Virus Assay		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Panther Fusion®	Hologic, Inc.	5
Respiratory Pathogens Flex (RP Flex) Extraction Tray	Luminex Corporation	1
Prodesse	Hologic, Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K141927	2014-10-09

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Lyra