What is FDA product code OCC?

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.

Immunology & Microbiology › Serological ReagentsRespiratory Virus Panel Nucleic Acid Assay System

Xpert FLU/RSV XC

Name: Xpert FLU/RSV XC
Brand: Xpert FLU/RSV XC

Xpert Flu/RSV XC is a cartridge based molecular test that detects and distinguishes influenza A, influenza B and respiratory syncytial virus RNA. It uses nasopharyngeal swabs or nasal…

Registry build 21.09.26

Xpert Flu/RSV XC is a cartridge based molecular test that detects and distinguishes influenza A, influenza B and respiratory syncytial virus RNA. It uses nasopharyngeal swabs or nasal aspirate and wash specimens from patients with respiratory infection symptoms. The assay runs on compatible Cepheid GeneXpert Dx or Infinity systems.

The single use cartridge contains the reagents and chambers for sample preparation and real time reverse transcription PCR. After prepared sample is added and the cartridge is loaded, the instrument processes the specimen and generates a result report. Internal controls check sample processing and probe performance.

Listed Item

Xpert FLU/RSV XC kit; 10 test kit

Result Scope

Results help diagnosis alongside clinical and epidemiological information. A negative result does not exclude infection and cannot be the sole basis for treatment decisions. The assay provides qualitative detection rather than a measurement of viral quantity.

1manufacturer

1catalogue number

8510(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 OCC
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for Xpert FLU/RSV XC
Listed by	Cepheid, United States
FDA product code	OCC
Device type	Respiratory Virus Panel Nucleic Acid Assay System
Device class	Class 2
Regulation	21 CFR 866.3980
Establishment	Contract manufacturer, Specification developer, Manufacturer, Exporter
510(k)	K142045
Record published	2018-01-29
Record revised	2023-12-18 (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
Storage	Storage environment temperature 2 to 28 °C

Catalogue Numbers

Catalogue numbers for Xpert FLU/RSV XC
Catalogue number	Size	Status
GXFLU/RSV-10		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Panther Fusion®	Hologic, Inc.	4
Prodesse	Hologic, Inc.	4
Solana	Diagnostic Hybrids, Inc.	2
Alere™ i Influenza A & B Control Swab Kit	Alere Scarborough, Inc.	1
Silaris RSV Supplemental Pack	Mesa Biotech, Inc.	1
Alere i RSV Control Swab Kit	Alere Scarborough, Inc.	1
ID NOW Influenza A & B 2 Control Swab Kit	Alere Scarborough, Inc.	1
Xpert Xpress Flu/RSV	Cepheid	1
ID NOW Influenza A & B Control Swab Kit	Alere Scarborough, Inc.	1
Simplexa™ Flu A/B & RSV Direct	DiaSorin Molecular LLC	1
Alere™ i Influenza A & B	Alere Scarborough, Inc.	1
Respiratory Virus Plus (RV+) Amplification Tray	Nanosphere, Inc.	1

Showing 12 of 39. All products under Respiratory Virus Panel Nucleic Acid Assay System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181289	2018-08-15
K180218	2018-07-24
K171552	2017-12-19
K162456	2017-02-13
K162331	2017-02-09
K151226	2015-12-03
K142045	2014-11-22
K123191	2012-12-21

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.