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.

Immunology & Microbiology › Serological ReagentsParainfluenza Multiplex Nucleic Acid Assay

Prodesse

Name: Prodesse
Brand: Prodesse

Catalogue number PROPARAFLU+ KIT, 100 REACTIONS, listed by Hologic, Inc., United States, under Parainfluenza Multiplex Nucleic Acid Assay. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product code

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 Prodesse
Listed by	Hologic, Inc., United States
FDA product code	OOU
Device type	Parainfluenza Multiplex Nucleic Acid Assay
Device class	Class 2
Regulation	21 CFR 866.3980
Establishment	Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K132238
Record published	2016-04-15
Record revised	2023-12-18 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2019-06-30
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Prodesse
Catalogue number	Size	Status
PROPARAFLU+ KIT, 100 REACTIONS		Withdrawn

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
Lyra	Quidel Corp.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K172282	2017-10-23
K153223	2015-12-09

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.