What is FDA product code OEM?

A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.

Panther Fusion® · Human Metapneumovirus (Hmpv) Rna Assay System → Immunology & Microbiology

Name: Panther Fusion®
Brand: Panther Fusion®

1manufacturer

1catalogue number

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 OEM
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	OEM
Device type	Human Metapneumovirus (Hmpv) Rna Assay System
Device class	Class 2
Regulation	21 CFR 866.3980
Establishment	Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K171963
Record published	2017-11-08
Record revised	2024-06-13 (version 7)

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 2 to 8 °C
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Panther Fusion®
Catalogue number	Size	Status
KIT, INTERNAL CONTROL -S, FUSION, IVD		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Prodesse	Hologic, Inc.	1
FilmArray® Respiratory Panel (RP)	BioFire Diagnostics, LLC	1
xTAG® RVP Fast (Respiratory Viral Panel Fast)	Luminex Molecular Diagnostics, Inc.	1
Lyra	Diagnostic Hybrids, Inc.	1

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Panther Fusion®
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Hologic, Inc.	510(k) number	2024-11-08	Class II	Unknown/Undetermined by firm	SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.	3
Hologic, Inc.	510(k) number	2019-10-10	Class II	Nonconforming Material/Component	Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient	47 kits

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.

Panther Fusion®