13 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nuclein, LLC
FDA registration
Nuclein, LLC·2 products·🇺🇸 United States
Nuclein, LLC
FDA registration
Nuclein, LLC·2 products·🇺🇸 United States
DASH® SARS-CoV-2 & Flu A/B Test Kit
FDA UDI
Nuclein, LLC·00850063063036·The DASH SARS-CoV-2 & Flu A/B Test is a rapid r...
DASH® Rapid PCR Instrument
FDA UDI
Nuclein, LLC·00850063063005·The DASH® Rapid PCR Instrument (DASH Instrument...
DASH® Negative Control Swabs Kit
FDA UDI
Nuclein, LLC·00850063063012·DASH® Negative Control swabs are intended for u...
DASH® SARS-CoV-2 & Flu A/B Positive Control Swabs Kit
FDA UDI
Nuclein, LLC·00850063063029·DASH® SARS-CoV-2 & Flu A/B Positive Control swa...
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
FDA Recall
Open, Classified
·Nuclein LLC·Product code QOF·June 25, 2025
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.
FDA Enforcement
Class II
·Ongoing·Nuclein LLC·August 13, 2025
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Enforcement
Class II
·Terminated·BioFire Diagnostics, LLC·May 8, 2019
FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PCH·March 6, 2019
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853,
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PAM·September 5, 2018
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BACT/ALERT FN Plus 410853/BACT/ALERT PF Plus 259790/BACT/ALERT SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PEN·January 22, 2020
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BACT/ALERT FN Plus 410853/BACT/ALERT PF Plus 259790/BACT/ALERT SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PEN·January 22, 2020