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

Cobas® Influenza A/B Quality Control Kit for Use on the Cobas® Liat® System

Name: cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System
Brand: cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System

Catalogue number 07402660190, listed by Roche Molecular Systems, Inc., United States, under Respiratory Virus Panel Nucleic Acid Assay System. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

4510(k) clearances naming this product code

3recalls on this 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 cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System
Listed by	Roche Molecular Systems, Inc., 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	Specification developer, Manufacturer, Exporter
Record published	2016-09-24
Record revised	2022-04-15 (version 3)

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

Catalogue Numbers

Catalogue numbers for cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System
Catalogue number	Size	Status
07402660190		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
K213822	2022-07-06
K210234	2021-02-16
K200065	2020-02-10
K191729	2019-07-24

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-05-17	Class III	Incorrect or no expiration date	Kit labeled with the incorrect expiration date.	194 distributed kits	2017-02-01
2016-05-09	Class II	Under Investigation by firm	Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.	2	2021-03-24
2015-07-24	Class II	Nonconforming Material/Component	Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.	5 pieces	2015-12-23

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.