|
Device |
respiratory virus panel nucleic acid assay system |
Definition |
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus. |
Product Code | OCC |
Regulation Number |
866.3980
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT DIAGNOSTICS SCARBOROUGH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ABBOTT LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALERE SCARBOROUGH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
APPLIED BIOCODE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARGENE SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOFIRE DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOFIRE DIAGNOSTICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CEPHEID |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
DIASORIN MOLECULAR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOCUS DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOCUS DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GEN-PROBE PRODESSE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GEN-PROBE PRODESSE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENMARK DIAGNOSTICS, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOLOGIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
IDAHO TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTELLIGENT MEDICAL DEVICES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IQUUM INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IQUUM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JANSSEN PHARMACEUTICA NV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUMINEX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MESA BIOTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOSPHERE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
NANOSPHERE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRODESSE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QIAGEN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QIAGEN, GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUIDEL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
QUIDEL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ROCHE MOLECULAR SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Alere Scarborough, Inc. dba Binax, Inc. |
II |
Jul-16-2015 |
2 |
Alere Scarborough, Inc. dba Binax, Inc. |
II |
May-26-2015 |
3 |
BioFire Diagnostics, LLC |
II |
Sep-11-2024 |
4 |
DiaSorin Molecular LLC |
II |
Mar-03-2023 |
5 |
Focus Diagnostics Inc |
II |
Apr-02-2016 |
6 |
Focus Diagnostics Inc |
II |
Jul-01-2014 |
7 |
Focus Diagnostics Inc |
II |
Jan-28-2014 |
8 |
Hologic, Inc |
II |
May-28-2020 |
9 |
Luminex Corporation |
II |
Jul-02-2021 |
10 |
Luminex Corporation |
II |
Oct-05-2020 |
11 |
Luminex Molecular Diagnostics |
II |
Oct-18-2019 |
12 |
Nanosphere, Inc. |
II |
Sep-23-2014 |
13 |
Quidel Corporation |
II |
Feb-22-2017 |
14 |
Roche Molecular Systems, Inc. |
II |
Jul-15-2016 |
15 |
Roche Molecular Systems, Inc. |
III |
Jul-13-2016 |
16 |
Roche Molecular Systems, Inc. |
II |
Sep-02-2015 |
|
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