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

Panther Fusion®

Name: Panther Fusion®
Brand: Panther Fusion®

The Panther Fusion® Paraflu assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of parainfluenza 1 virus,…

Registry build 21.09.26

The Panther Fusion® Paraflu assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus (HPIV-1, HPIV-2, HPIV-3, and HPIV-4).

1manufacturer

5catalogue numbers in this listing

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 Panther Fusion®
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)	K172282
Record published	2017-11-08
Record revised	2024-06-13 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Panther Fusion®
Catalogue number	Size	Status
ELUTION KIT, PANTHER FUSION, 2400T, IVD		In distribution
RECON-1 KIT, PANTHER FUSION, 1920T, IVD		In distribution
KIT, EXTRACTION REAGENTS – S, FUSION, IVD		In distribution
PARAFLU KIT, PANTHER FUSION, 96T, IVD		In distribution
PARAFLU CTRLS KIT, PANTHER FUSION, IVD		In distribution

Same Product Code

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