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

Simplexa™ Flu A/B & RSV Direct Gen II

Name: Simplexa™ Flu A/B & RSV Direct Gen II
Brand: Simplexa™ Flu A/B & RSV Direct Gen II

Catalogue number MOL2655, listed by DiaSorin Molecular LLC, 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

1510(k) clearance

4recalls 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 Simplexa™ Flu A/B & RSV Direct Gen II
Listed by	DiaSorin Molecular LLC, 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
510(k)	K201505
Record published	2020-08-29
Record revised	2024-07-08 (version 4)

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 -30 to -10 °C

Catalogue Numbers

Catalogue numbers for Simplexa™ Flu A/B & RSV Direct Gen II
Catalogue number	Size	Status
MOL2655		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
K201505	2020-08-22

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Simplexa™ Flu A/B & RSV Direct Gen II
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
DiaSorin Molecular LLC	510(k) number	2023-01-30	Class II	Device Design	Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.	4142

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. 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
2016-02-10	Class II	Under Investigation by firm	Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a f	7421 units	2016-06-16
2014-05-15	Class II	Device Design	Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa” Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic	614 kits	2014-12-31
2014-01-10	Class II	Pending	Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positi	1,052 kits	2014-10-15

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.