Panels › Microbiology › Product code OCC · Class 2
Respiratory Virus Panel Nucleic Acid Assay System
Regulation 866.3980
2510(k)s in 12 months (80 all time)
0recalls in 12 months (25 all time)
23recalls that name a 510(k)
Top companies in OCC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 29, 2025 | BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems Open, Classified |
OCC | None listed |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW RSV 24T
Product Name: ID NOW RSV 24T
Model/Catalog Number: 435-000
Software Version: N/A
Product Description: Respiratory virus panel nucleic acid assay system
Component: No Open, Classified |
OCC | K161375 |
| Apr 15, 2025 | Abbott Diagnostics Scarborough, Inc. Brand Name: ID NOW RSV 24T
Product Name: ID NOW RSV 24T
Model/Catalog Number: 435-000
Software Version: N/A
Product Description: Respiratory virus panel nucleic acid assay system
Component: No Open, Classified |
OCC | K161375 |
| Oct 9, 2024 | Luminex Molecular Diagnostics Inc NxTAG Respiratory Pathogen Panel, REF: I051C0447 Open, Classified |
OCC | K152386 K193167 |
| Sep 11, 2024 | BioFire Diagnostics, LLC FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U Open, Classified |
OCC | K160068 |
| Mar 3, 2023 | DiaSorin Molecular LLC Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5. Open, Classified |
OCC | K201505 |
| Oct 30, 2020 | Luminex Corporation Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026 Open, Classified |
OCC | None listed |
| Oct 30, 2020 | Luminex Corporation Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022 Open, Classified |
OCC | K123197 |
| Oct 30, 2020 | Luminex Corporation Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023 Open, Classified |
OCC | K140083 |
| Oct 30, 2020 | Luminex Corporation Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021 Open, Classified |
OCC | K132843 |
| Oct 30, 2020 | Luminex Corporation Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018 Open, Classified |
OCC | K122514 |
| Oct 30, 2020 | Luminex Corporation Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024 Open, Classified |
OCC | K143653 |
| Oct 10, 2019 | Hologic, Inc Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium H Open, Classified |
OCC | K171963 |
| Jul 16, 2019 | Luminex Molecular Diagnostics xTAG Respiratory Viral Panel (RVP):
Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111
in vitro diagnostic test Open, Classified |
OCC | K081483 K091667 +2 |
| Dec 10, 2018 | Luminex Corporation VERIGENE Processor SP
Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids Open, Classified |
OCC | K143653 |
| Feb 22, 2017 | Quidel Corporation Influenza Transport Swab Packages, Reference #20171,
One lot with 1010 packages (each package contains 25 transport tubes).
The Influenza Swabs in dry transport tubes are intended for use with influe Terminated |
OCC | K141520 |
| Jul 13, 2016 | Roche Molecular Systems, Inc. cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay. Terminated |
OCC | K111387 |
| May 9, 2016 | Roche Molecular Systems, Inc. cobas Liat Analyzer Terminated |
OCC | K111387 |
| Apr 2, 2016 | Focus Diagnostics Inc Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455)
Model Number: MOL2650, MOL1451, MOL1452, MOL1455 Terminated |
OCC | K152408 |
| Sep 2, 2015 | Roche Molecular Systems, Inc. cobas Liat Analyzer, for in vitro diagnostic use. Terminated |
OCC | K111387 |
| Jul 16, 2015 | Alere Scarborough, Inc. dba Binax, Inc. Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024
The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing Terminated |
OCC | K141520 |
| May 26, 2015 | Alere Scarborough, Inc. dba Binax, Inc. Alere i Influenza A & B
Product Usage:
The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amp Terminated |
OCC | K141520 |
| Sep 23, 2014 | Nanosphere, Inc. The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory viru Terminated |
OCC | K103209 |
| Jul 1, 2014 | Focus Diagnostics Inc Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650.
510(k) K120413 Simplexa" Flu A/B & RSV Direct.
The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Inte Terminated |
OCC | K120413 |
| Jan 28, 2014 | Focus Diagnostics Inc Simplexa Flu A/B & RSV Direct assay, Model MOL2650.
The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative d Terminated |
OCC | K120413 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.