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.

GeneXpert® · Respiratory Specimen Nucleic Acid Sars-Cov-2 Test → Immunology & Microbiology

Name: GeneXpert®
Brand: GeneXpert®

1manufacturer

1catalogue number

2510(k) clearances naming this product code

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 GeneXpert®
Listed by	Cepheid, 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	Contract manufacturer, Specification developer, Manufacturer, Exporter
Record published	2024-01-22

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 2 to 28 °C

Catalogue Numbers

Catalogue numbers for GeneXpert®
Catalogue number	Size	Status
XPRS-COV2-10		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
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
Simplexa COVID-19 Direct	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
K242109	2025-01-15
K230440	2023-10-13

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.

GeneXpert®