OCC
FILMARRAY RESPIRATORY PANEL (RP)
- Advisory panel
- Microbiology
- Total cleared
- 78
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OCC
- K242613 — NxTAG® Respiratory Pathogen Panel
- K232775 — ID NOW Influenza A & B 2
- K231017 — Panther Fusion AdV/hMPV/RV Assay
- K213822 — cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
- K210234 — cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
- K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
- 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
- K192485 — BioCode Respiratory Pathogen Panel (RPP)
- K193167 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- K191729 — Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
- K191534 — ID NOW Influenza A & B 2
- K183597 — QIAstat-Dx Respiratory Panel
- K181443 — Accula RSV Test
- 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
- K180218 — Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- K173932 — Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
- K171552 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
- K172629 — Panther Fusion AdV/hMPV/RV Assay
- K171974 — Solana RSV+hMPV Assay
- K171792 — Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
- 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
- K163628 — Idylla Respiratory (IFV-RSV) Panel
- K163636 — ePlex Respiratory Pathogen Panel
- K170604 — FilmArray Respiratory Panel 2 (RP2)
- K162456 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- K162331 — Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- K163266 — Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
- K152579 — FilmArray Respiratory Panel EZ (RP EZ)
- K161814 — Solana Influenza A+B Assay
- K161375 — Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
- K161220 — ARIES® Flu A/B & RSV Assay
- K153544 — cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
- K160068 — FilmArray Respiratory Panel (RP) for use with FilmArray Torch
- K152386 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- K151226 — Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
- K153219 — ProFlu+ Assay
- K152523 — JBAIDS Influenza A & B Detection Kit
- K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
- K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
- K151464 — Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
- K143080 — FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
- K142365 — Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
- K142045 — XPERT FLU/RSV XC ASSAY
- K141931 — LYRA ADENOVIRUS ASSAY
- K141520 — ALERE I INFLUENZA A & B
- K131813 — QUIDEL MOLECULAR RSV + HMPV ASSAY
- K131584 — IMDX FLU A/B AND RSV FOR ABBOTT M2000
- K132159 — PROADENO+ ASSAY
- K132129 — PRODESSE PROFLU+ ASSAY
- K123620 — FILMARRAY RESPIRATORY PANEL (RP)
- K121942 — ADENOVIRUS R-GENE US
- K121003 — ABBOTT PLEX-ID FLU ASSAY
- K123191 — XPERT FLU
- K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
- K120267 — FILMARRAY RP PANEL
- K112781 — TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)
- K113323 — ARTUS INFL A/B RG RT-PCR KIT
- K112172 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY
- K111775 — JBAIDS INFLUENZA A&B DETECTION KIT
- K112199 — XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
- K111387 — LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
- K103776 — XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
- K110968 — PROFLU+ ASSAY
- K110764 — FILMARRAY RP PANEL
- K103175 — FILMARRAY RESPIRATORY PANEL (RP)
- K103209 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
- K102952 — PRODESSE PROADENO
- K102170 — SIMPLEXA FLU A/B & RSV
- K093337 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
- K092957 — VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
- K092566 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)
- K092500 — MODIFICATION TO PROFLU+ ASSAY
- K091667 — XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116
- K083088 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
- K081483 — XTAG RESPIRATORY VIRAL PANEL
- K081030 — MODIFICATION TO PROFLU+ ASSAY
- K073029 — PROFLU+ ASSAY
- DEN070013 — ID-TAG RESPIRATORY VIRAL PANEL
Data sourced from openFDA. This site is unofficial and independent of the FDA.