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

Prodesse

Name: Prodesse
Brand: Prodesse

4 catalogue numbers from PROFLU+ ASSAY KIT, 1,500 REACTIONS, listed by Hologic, 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

4catalogue numbers in this listing

4510(k) clearances naming this product code

1recall

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 Prodesse
Listed by	Hologic, 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	Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K132129
Record published	2016-04-15
Record revised	2023-12-18 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2019-06-30
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Prodesse
Catalogue number	Size	Status
PROFLU+ ASSAY KIT, 1,500 REACTIONS		Withdrawn
PROFLU+ ASSAY KIT, 2,000 REACTIONS		Withdrawn
PRODESSE PROFLU+ ASSAY		Withdrawn
PROADENO+ KIT, 100 REACTIONS		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Panther Fusion®	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
Accula Flu A / B Test	Mesa Biotech, 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
K231017	2023-05-05
K172629	2017-12-04
K171963	2017-09-26
K153219	2015-11-20

Recalls

1 of these is 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
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.