Product Code: OCC

Products Classified as OCC

3524

Respiratory Virus Panel Nucleic Acid Assay System

Respiratory Viral Panel Multiplex Nucleic Acid Assay.

Total Product Life Cycle (TPLC) Devices

3524

Respiratory Virus Panel Nucleic Acid Assay System

Respiratory Viral Panel Multiplex Nucleic Acid Assay.

Pre-market Notifications for OCC

K213822	Cobas Influenza A/B & RSV Nucleic Acid Test For Use On The Cobas Liat System	Roche Molecular Systems, Inc.
K201505	Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack	DiaSorin Molecular LLC
K200065	Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat System, Cobas Influenza A/B & RSV Nucleic Acid Test For Use On The Cobas Liat System, Cobas Strep A Nucleic Acid Test For Use On The Cobas Liat System	Roche Molecular Systems, Inc.
K193167	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software	Luminex Molecular Diagnostics, Inc.
K192485	BioCode Respiratory Pathogen Panel (RPP)	Applied BioCode, Inc.
K191729	Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat System	Roche Molecular Systems, Inc.
K191534	ID NOW Influenza A & B 2	Abbott Diagnostics Scarborough, Inc.
K183597	QIAstat-Dx Respiratory Panel	QIAGEN GmbH
K181443	Accula RSV Test	Mesa Biotech, Inc.
K181289	Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System And GeneXpert Infinity-80 System	Cepheid
K180218	Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV	Cepheid
K173932	Alere I Influenza A & B, Alere I Strep A, Alere I RSV, Alere I Influenza A & B 2	Alere Scarborough, Inc.
K172629	Panther Fusion AdV/hMPV/RV Assay	Hologic, Inc.
K171974	Solana RSV+hMPV Assay	Quidel Corporation
K171963	Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes	Hologic, Inc.

Global Unique Device Identification Database

• 00815381020079: Respiratory Virus Panel Nucleic Acid Assay System
• 00875197005639: Respiratory Virus Panel Nucleic Acid Assay System
• 00875197005608: Respiratory Virus Panel Nucleic Acid Assay System
• 00857573006294: Respiratory Virus Panel Nucleic Acid Assay System
• 00857573006232: Respiratory Virus Panel Nucleic Acid Assay System
• 00857573006133: Respiratory Virus Panel Nucleic Acid Assay System
• 00851458005112: Respiratory Virus Panel Nucleic Acid Assay System
• 00851458005068: Respiratory Virus Panel Nucleic Acid Assay System
• 07613336129685: Respiratory Virus Panel Nucleic Acid Assay System
• 07332940006044: Respiratory Virus Panel Nucleic Acid Assay System
• 07332940005696: Respiratory Virus Panel Nucleic Acid Assay System
• 07332940005177: Respiratory Virus Panel Nucleic Acid Assay System
• 07332940000783: Respiratory Virus Panel Nucleic Acid Assay System
• B54010270: Respiratory Virus Panel Nucleic Acid Assay System
• B54010240: Respiratory Virus Panel Nucleic Acid Assay System

Maude Adverse Events

PANTHER FUSION ADV/HMPV/RV ASSAY	HOLOGIC, INC.	2019-10-22
ID NOW INFLUENZA A & B2	ALERE SCARBOROUGH, INC.	2019-01-30
ALERE? I INFLUENZA A&B	ALERE SCARBOROUGH, INC.	2018-02-01
XPERT FLU	CEPHEID	2017-03-24
XTAG RESPIRATORY VIRAL PANEL	LUMINEX MOLECULAR DIAGNOSTICS	2016-11-23
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-05-18
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-05-18
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-05-18
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-05-13
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-04-15
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-04-15
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-04-15
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-04-15
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-10
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-10
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-10
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-10
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-10
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-06
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-06
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-06
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-06
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-06
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL	FOCUS DIAGNOSTICS	2016-03-04
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK	FOCUS DIAGNOSTICS	2016-03-03
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK	FOCUS DIAGNOSTICS	2016-03-03
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK	FOCUS DIAGNOSTICS	2016-03-03
SIMPLEXA FLU A/B & RSV DIRECT AND SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK	FOCUS DIAGNOSTICS	2016-03-03
PRODESSE PROFLU ASSAY	HOLOGIC INCORPORATED	2015-12-04
SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	FOCUS DIAGNOSTICS, INC.	2014-12-29
SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	FOCUS DIAGNOSTICS, INC.	2014-12-29
SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	FOCUS DIAGNOSTICS, INC.	2014-12-29
SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	FOCUS DIAGNOSTICS, INC.	2014-12-29
SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	FOCUS DIAGNOSTICS, INC.	2014-12-29
SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	FOCUS DIAGNOSTICS, INC.	2014-12-29
SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	FOCUS DIAGNOSTICS, INC.	2014-12-29
SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	FOCUS DIAGNOSTICS, INC.	2014-12-29
SIMPLEXA FLU A/B AND RSV DIRECT ASSAY	FOCUS DIAGNOSTICS, INC.	2014-12-29