What is FDA product code OEP?

A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.

Immunology & Microbiology › Serological ReagentsInfluenza A Virus Subtype Differentiation Nucleic Acid Assay

Respiratory Pathogens Flex (RP Flex) Amplification Tray

Name: Respiratory Pathogens Flex (RP Flex) Amplification Tray
Brand: Respiratory Pathogens Flex (RP Flex) Amplification Tray

Catalogue number 20-011-024, listed by Luminex Corporation, United States, under Influenza A Virus Subtype Differentiation Nucleic Acid Assay. 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 OEP
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for Respiratory Pathogens Flex (RP Flex) Amplification Tray
Listed by	Luminex Corporation, United States
FDA product code	OEP
Device type	Influenza A Virus Subtype Differentiation Nucleic Acid Assay
Device class	Class 2
Regulation	21 CFR 866.3980
Establishment	Contract manufacturer, Remanufacturer, Complaint-file establishment, Manufacturer
510(k)	K143653
Record published	2019-12-05
Record revised	2023-12-18 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature up to -20 °C

Catalogue Numbers

Catalogue numbers for Respiratory Pathogens Flex (RP Flex) Amplification Tray
Catalogue number	Size	Status
20-011-024		In distribution

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Respiratory Pathogens Flex (RP Flex) Amplification Tray
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Luminex Corporation	510(k) number	2020-10-30	Class II	Device Design	Potential for a false-negative result.	38,990
Luminex Corporation	510(k) number	2018-12-10	Class II	Component design/selection	No results/incorrect results due to failure of the hybridization heater.	1 system

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.