What is FDA product code OZX?

A qualitative in vitro diagnostic assay intended to detect Mycoplasma pneumoniae DNA extracted from human respiratory specimens. Detection of Mycoplasma pneumoniae DNA aids in the diagnosis of Mycoplasma pneumoniae respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

Immunology & Microbiology › Serological ReagentsMycoplasma Pneumoniae Dna Assay System

FilmArray® Respiratory Panel (RP) EZ

Name: FilmArray® Respiratory Panel (RP) EZ
Brand: FilmArray® Respiratory Panel (RP) EZ

Catalogue number RFIT-ASY-0120, listed by BioFire Diagnostics, LLC, United States, under Mycoplasma Pneumoniae Dna Assay System. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

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 OZX
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for FilmArray® Respiratory Panel (RP) EZ
Listed by	BioFire Diagnostics, LLC, United States
FDA product code	OZX
Device type	Mycoplasma Pneumoniae Dna Assay System
Device class	Class 2
Regulation	21 CFR 866.3980
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K152579
Record published	2016-12-06
Record revised	2022-05-03 (version 6)

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
Distribution end date	2021-12-08

Catalogue Numbers

Catalogue numbers for FilmArray® Respiratory Panel (RP) EZ
Catalogue number	Size	Status
RFIT-ASY-0120		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Alethia™ Mycoplasma Direct External Control Kit	Meridian Bioscience, Inc.	1

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.