What is FDA product code OTG?

A non-SARS coronavirus multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of coronavirus 229E, coronavirus NL63, coronavirus HKU1 and Coronavirus OC43 nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human non-SARS coronavirus nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract non-SARS coronavirus infections if used in conjunction with other clinical and laboratory findings.

Immunology & Microbiology › Serological ReagentsNon-Sars Coronavirus Multiplex Nucleic Acid Assay

NxTAG® Respiratory Pathogen Panel

Name: NxTAG® Respiratory Pathogen Panel
Brand: NxTAG® Respiratory Pathogen Panel

The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from…

Registry build 21.09.26

The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection.

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

Record

Regulatory record for NxTAG® Respiratory Pathogen Panel
Listed by	Luminex Molecular Diagnostics, Inc., Canada
FDA product code	OTG
Device type	Non-Sars Coronavirus Multiplex Nucleic Acid Assay
Device class	Class 2
Regulation	21 CFR 866.3980
Establishment	Manufacturer
510(k)	K152386
Record published	2016-09-09
Record revised	2024-11-29 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for NxTAG® Respiratory Pathogen Panel
Catalogue number	Size	Status
I051C0447		In distribution

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 NxTAG® Respiratory Pathogen Panel
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Luminex Molecular Diagnostics, Inc.	510(k) number	2024-09-05	Class II	Device Design	Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for an	3375

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.