What is FDA product code QQX?

A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

Immunology & Microbiology › Serological ReagentsRespiratory Specimen Nucleic Acid Sars-Cov-2 Test

Simplexa COVID-19 Direct

Name: Simplexa COVID-19 Direct
Brand: Simplexa COVID-19 Direct

Catalogue number MOL4150, listed by DiaSorin Molecular LLC, United States, under Respiratory Specimen Nucleic Acid Sars-Cov-2 Test. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code QQX
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15

Record

Regulatory record for Simplexa COVID-19 Direct
Listed by	DiaSorin Molecular LLC, United States
FDA product code	QQX
Device type	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Device class	Class 2
Regulation	21 CFR 866.3981
Establishment	Specification developer, Manufacturer, Exporter
Record published	2023-06-16

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 -30 to -10 °C

Catalogue Numbers

Catalogue numbers for Simplexa COVID-19 Direct
Catalogue number	Size	Status
MOL4150		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aptima®	Hologic, Inc.	3
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer	Life Technologies Corporation	3
COVID-19 Coronavirus Real Time PCR Kit	Jiangsu Bioperfectus Technologies Co., Ltd.	2
BioFire® COVID-19 Test 2	BioFire Defense, LLC	2
cobas® SARS-CoV-2 Qualitative 480T	Roche Molecular Systems, Inc.	1
Simplexa COVID-19 Positive Control GEN II Pack	DiaSorin Molecular LLC	1
GeneXpert®	Cepheid	1
BD Respiratory Viral Panel-SCV2 for BD MAX™ System	Becton, Dickinson AND Company	1
cobas® SARS-CoV-2 Qualitative Control Kit	Roche Molecular Systems, Inc.	1
Simplexa COVID-19 Positive Control Pack	DiaSorin Molecular LLC	1
cobas® SARS-CoV-2 Qualitative 192T	Roche Molecular Systems, Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K212147	2022-09-13

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Simplexa COVID-19 Direct
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
DiaSorin Molecular LLC	UDI-DI	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.	90142

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.