BD Max Staphsr Assay, Instrument

Q: What is the product code of K132822?

The FDA product code is NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, a Class II (moderate risk) device regulated under 21 CFR 866.1640.

FDA 510(k) K132822 · Geneohm Sciences Canada, Inc. (Bd Diagnostics)

Substantially Equivalent

510(k) numberK132822

Submission

Device name: BD Max Staphsr Assay, Instrument
Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics)
Quebec, CA
Received: September 9, 2013
Decision date: November 26, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.1640
Specialty: Microbiology

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.

Other 510(k)s with product code NQX

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K243625	Xpert MRSA/SA SSTINQX · Special	Cepheid®	12/18/2024SE
K243070	Xpert® SA Nasal CompleteNQX · Special	Cepheid®	10/25/2024SE
K191742	ARIES MRSA AssayNQX · Traditional	Luminex Corporation	09/25/2019SE
K190771	Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…NQX · Special	Cepheid	04/25/2019SE
K162444	Xpert MRSA NxGNQX · Traditional	Cepheid	11/23/2016SE
K142721	cobas MRSA/SA TestNQX · Traditional	Roche Molecular Systems, Inc.	12/17/2014SE
K133605	BD Max Mrsa XT, BD Max InstrumentNQX · Traditional	Geneohm Sciences Canada, Inc.	12/20/2013SE
K132468	Mrsa/Sa Elite MGB, Elite MGB SoftwareNQX · Traditional	Elitechgroup Epoch Biosciences	10/17/2013SE
K130894	Xpert Mrsa/Sa Blood Culture Assay; Genexpert DX Systems (Gx-I, Gx-Ii, Gx-Iv, Gx-Xvi)…NQX · Traditional	Cepheid	06/20/2013SE
K120138	BD Max Mrsa Assay, BD Max InstrumentNQX · Traditional	Bd Diagnostics (Geneohm Sciences Canada, Inc)	07/05/2012SE

More from Bd Diagnostics (Geneohm Sciences Canada, Inc)

510(k)	Device	Decision
K191957	BD MAX Vaginal PanelPQA · Traditional	10/21/2019SE
K130470	BD Max Cdiff Assay, BD Max InstrumentOZN · Traditional	04/02/2013SE

Questions and answers

When was BD Max Staphsr Assay, Instrument cleared by the FDA?

BD Max Staphsr Assay, Instrument (K132822) received a 510(k) decision of Substantially Equivalent on November 26, 2013, 78 days after the submission was received.

What is the product code of K132822?

The FDA product code is NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, a Class II (moderate risk) device regulated under 21 CFR 866.1640.