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

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer

Name: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer
Brand: Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer

The TaqPath COVID-19 Diagnostic PCR Control Dilution Buffer is supplied as a reagent component of the TaqPath COVID-19 Diagnostic PCR Kit, alongside the positive RNA control and multiplex…

Registry build 21.09.26

The TaqPath COVID-19 Diagnostic PCR Control Dilution Buffer is supplied as a reagent component of the TaqPath COVID-19 Diagnostic PCR Kit, alongside the positive RNA control and multiplex assay reagents.

The kit provides five boxes, each containing two 250 microliter tubes of this buffer. Within the kit, multiplex assays and a separate positive RNA control support qualitative detection of SARS-CoV-2 RNA in respiratory specimens.

Listed Item

Part 3 of 3 of TaqPath™ COVID-19 Diagnostic PCR Kit REF A58505

Laboratory Context

The complete diagnostic assay is intended for use in laboratories certified to perform high-complexity testing. The buffer remains a component used alongside the assay and control reagents.

1manufacturer

3catalogue numbers in this listing

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 Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer
Listed by	Life Technologies Corporation, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K233453
Record published	2025-02-17

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer
Catalogue number	Per pack	Status
A57740	2	In distribution
966136	2	In distribution
A57297		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aptima®	Hologic, Inc.	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
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
K233453	2024-07-10

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.