Regulatory Tracker

FDA, CE-IVD, WHO PQ, and EUA status across all products

510(k)

PMA

EUA

CE-IVD

RUO

WHO PQ

Product	Manufacturer	Authority	Status	Submission #	Type	Approval Date	Risk Class
BIOFIRE FILMARRAY Respiratory Panel 2.1	bioMérieux	FDA	510(k) Cleared	K213178	510(k)	10/15/2021	—
BIOFIRE FILMARRAY Respiratory Panel 2.1	bioMérieux	EMA / CE-IVD	CE-IVD	—	—	—	Class C
BIOFIRE FILMARRAY Blood Culture Identification Panel 2	bioMérieux	FDA	510(k) Cleared	K173409	510(k)	6/30/2017	—
BIOFIRE FILMARRAY Blood Culture Identification Panel 2	bioMérieux	EMA / CE-IVD	CE-IVD	—	—	—	Class C
BIOFIRE FILMARRAY Meningitis/Encephalitis Panel	bioMérieux	FDA	510(k) Cleared	K152715	510(k)	10/7/2015	—
BIOFIRE FILMARRAY Meningitis/Encephalitis Panel	bioMérieux	EMA / CE-IVD	CE-IVD	—	—	—	Class C
BIOFIRE FILMARRAY GI Panel	bioMérieux	FDA	510(k) Cleared	K143072	510(k)	5/14/2014	—
BIOFIRE FILMARRAY GI Panel	bioMérieux	EMA / CE-IVD	CE-IVD	—	—	—	Class C
cobas SARS-CoV-2 & Influenza A/B	Roche Diagnostics	FDA	EUA	EUA202543	EUA	8/1/2020	—
cobas SARS-CoV-2 & Influenza A/B	Roche Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
cobas HIV-1/HIV-2 Qualitative Test	Roche Diagnostics	FDA	PMA Approved	P160030	PMA	3/10/2017	—
cobas HIV-1/HIV-2 Qualitative Test	Roche Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
cobas HCV Quantitative Nucleic Acid Test	Roche Diagnostics	FDA	PMA Approved	P140020	PMA	4/22/2015	—
cobas HCV Quantitative Nucleic Acid Test	Roche Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
cobas MTB/RIF	Roche Diagnostics	FDA	510(k) Cleared	K211234	510(k)	5/10/2021	—
cobas MTB/RIF	Roche Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Alinity m SARS-CoV-2 AMP Kit	Abbott Diagnostics	FDA	EUA	EUA202001	EUA	3/18/2020	—
Alinity m SARS-CoV-2 AMP Kit	Abbott Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
BinaxNOW COVID-19 Antigen Card	Abbott Diagnostics	FDA	EUA	EUA202002	EUA	8/26/2020	—
BinaxNOW COVID-19 Antigen Card	Abbott Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class B
Alinity m Resp-4-Plex	Abbott Diagnostics	FDA	EUA	EUA202101	EUA	1/15/2021	—
Alinity m Resp-4-Plex	Abbott Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Architect HIV Ag/Ab Combo	Abbott Diagnostics	FDA	PMA Approved	P120024	PMA	6/18/2013	—
Architect HIV Ag/Ab Combo	Abbott Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Aptima Combo 2 Assay	Hologic	FDA	510(k) Cleared	K021345	510(k)	7/1/2002	—
Aptima Combo 2 Assay	Hologic	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Aptima HIV-1 Quant Dx Assay	Hologic	FDA	PMA Approved	P150047	PMA	6/9/2016	—
Aptima HIV-1 Quant Dx Assay	Hologic	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Aptima Trichomonas vaginalis Assay	Hologic	FDA	510(k) Cleared	K101325	510(k)	3/1/2011	—
Aptima Trichomonas vaginalis Assay	Hologic	EMA / CE-IVD	CE-IVD	—	—	—	Class C
BD MAX CT/GC/TV	Becton Dickinson (BD)	FDA	510(k) Cleared	K152678	510(k)	2/1/2016	—
BD MAX CT/GC/TV	Becton Dickinson (BD)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
BD Veritor System Flu A+B	Becton Dickinson (BD)	FDA	510(k) Cleared	K163498	510(k)	4/1/2017	—
BD Veritor System Flu A+B	Becton Dickinson (BD)	EMA / CE-IVD	CE-IVD	—	—	—	Class B
BD MAX MRSA XT Assay	Becton Dickinson (BD)	FDA	510(k) Cleared	K143012	510(k)	9/1/2014	—
BD MAX MRSA XT Assay	Becton Dickinson (BD)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
QIAstat-Dx Respiratory SARS-CoV-2 Panel	Qiagen	FDA	EUA	EUA202101	EUA	2/1/2021	—
QIAstat-Dx Respiratory SARS-CoV-2 Panel	Qiagen	EMA / CE-IVD	CE-IVD	—	—	—	Class C
QIAstat-Dx Gastrointestinal Panel	Qiagen	FDA	510(k) Cleared	K202345	510(k)	11/1/2020	—
QIAstat-Dx Gastrointestinal Panel	Qiagen	EMA / CE-IVD	CE-IVD	—	—	—	Class C
QuantiFERON-TB Gold Plus	Qiagen	FDA	510(k) Cleared	K140823	510(k)	11/1/2014	—
QuantiFERON-TB Gold Plus	Qiagen	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Allplex SARS-CoV-2/FluA/FluB/RSV Assay	Seegene	FDA	EUA	EUA202102	EUA	3/1/2021	—
Allplex SARS-CoV-2/FluA/FluB/RSV Assay	Seegene	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Allplex STI Essential Assay	Seegene	FDA	RUO	—	RUO	—	—
Allplex STI Essential Assay	Seegene	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Xpert MTB/RIF Ultra	Cepheid (Danaher)	FDA	510(k) Cleared	K173245	510(k)	9/1/2017	—
Xpert MTB/RIF Ultra	Cepheid (Danaher)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Xpert HIV-1 Qual	Cepheid (Danaher)	FDA	PMA Approved	P160031	PMA	6/1/2017	—
Xpert HIV-1 Qual	Cepheid (Danaher)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Xpert MRSA/SA SSTI	Cepheid (Danaher)	FDA	510(k) Cleared	K141234	510(k)	2/1/2015	—
Xpert MRSA/SA SSTI	Cepheid (Danaher)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Xpert Flu/RSV XC	Cepheid (Danaher)	FDA	510(k) Cleared	K182345	510(k)	1/1/2019	—
Xpert Flu/RSV XC	Cepheid (Danaher)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
NxTAG Respiratory Pathogen Panel	Luminex (DiaSorin Molecular)	FDA	510(k) Cleared	K152890	510(k)	4/1/2016	—
NxTAG Respiratory Pathogen Panel	Luminex (DiaSorin Molecular)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Meridian Illumigene C. difficile	Meridian Bioscience	FDA	510(k) Cleared	K101234	510(k)	6/1/2011	—
Meridian Illumigene C. difficile	Meridian Bioscience	EMA / CE-IVD	CE-IVD	—	—	—	Class C
TaqPath COVID-19 Combo Kit	Thermo Fisher Scientific	FDA	EUA	EUA202003	EUA	4/1/2020	—
TaqPath COVID-19 Combo Kit	Thermo Fisher Scientific	EMA / CE-IVD	CE-IVD	—	—	—	Class C
ADVIA Centaur HIV Ag/Ab Combo	Siemens Healthineers	FDA	PMA Approved	P130009	PMA	1/1/2014	—
ADVIA Centaur HIV Ag/Ab Combo	Siemens Healthineers	EMA / CE-IVD	CE-IVD	—	—	—	Class C
MALDI Biotyper CA System	Bruker	FDA	510(k) Cleared	K143010	510(k)	1/1/2015	—
MALDI Biotyper CA System	Bruker	EMA / CE-IVD	CE-IVD	—	—	—	Class C
DPP HIV 1/2 Assay	Chembio Diagnostics	FDA	PMA Approved	P120006	PMA	8/1/2012	—
DPP HIV 1/2 Assay	Chembio Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
DPP Syphilis Screen & Confirm	Chembio Diagnostics	FDA	510(k) Cleared	K181234	510(k)	9/1/2018	—
DPP Syphilis Screen & Confirm	Chembio Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
STANDARD Q COVID-19 Ag Test	SD Biosensor	FDA	EUA	EUA202103	EUA	4/1/2021	—
STANDARD Q COVID-19 Ag Test	SD Biosensor	EMA / CE-IVD	CE-IVD	—	—	—	Class B
STANDARD Q Malaria P.f/Pan Ag Test	SD Biosensor	FDA	510(k) Cleared	K201234	510(k)	6/1/2020	—
STANDARD Q Malaria P.f/Pan Ag Test	SD Biosensor	EMA / CE-IVD	CE-IVD	—	—	—	Class B
ePlex Respiratory Pathogen Panel 2	GenMark Diagnostics (Roper Technologies)	FDA	EUA	EUA202104	EUA	5/1/2021	—
ePlex Respiratory Pathogen Panel 2	GenMark Diagnostics (Roper Technologies)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
ePlex Blood Culture Identification Gram-Positive Panel	GenMark Diagnostics (Roper Technologies)	FDA	510(k) Cleared	K192345	510(k)	1/1/2020	—
ePlex Blood Culture Identification Gram-Positive Panel	GenMark Diagnostics (Roper Technologies)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
LIAISON MDX SARS-CoV-2 Ag	DiaSorin	FDA	EUA	EUA202105	EUA	6/1/2021	—
LIAISON MDX SARS-CoV-2 Ag	DiaSorin	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Sentosa SA SARS-CoV-2 Assay	Vela Diagnostics	FDA	EUA	EUA202106	EUA	7/1/2021	—
Sentosa SA SARS-CoV-2 Assay	Vela Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Accelerate PhenoTest BC Kit	Accelerate Diagnostics	FDA	510(k) Cleared	K161234	510(k)	2/1/2017	—
Accelerate PhenoTest BC Kit	Accelerate Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Unyvero HPN Hospitalized Pneumonia Panel	Curetis (OpGen)	FDA	510(k) Cleared	K202456	510(k)	12/1/2020	—
Unyvero HPN Hospitalized Pneumonia Panel	Curetis (OpGen)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
cobas Liat Influenza A/B & RSV	Roche Diagnostics	FDA	510(k) Cleared	K181567	510(k)	11/1/2018	—
cobas Liat Influenza A/B & RSV	Roche Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
ID NOW Strep A 2	Abbott Diagnostics	FDA	510(k) Cleared	K192001	510(k)	9/1/2019	—
ID NOW Strep A 2	Abbott Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class B
artus HCV RG RT-PCR Kit	Qiagen	FDA	RUO	—	RUO	—	—
artus HCV RG RT-PCR Kit	Qiagen	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Xpert Norovirus	Cepheid (Danaher)	FDA	RUO	—	RUO	—	—
Xpert Norovirus	Cepheid (Danaher)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Applied Biosystems HIV-1 Genotyping Kit	Thermo Fisher Scientific	FDA	PMA Approved	P050040	PMA	3/1/2006	—
Applied Biosystems HIV-1 Genotyping Kit	Thermo Fisher Scientific	EMA / CE-IVD	CE-IVD	—	—	—	Class C
STANDARD Q Dengue Duo Ag/Ab Combo	SD Biosensor	FDA	510(k) Cleared	K201567	510(k)	9/1/2020	—
STANDARD Q Dengue Duo Ag/Ab Combo	SD Biosensor	EMA / CE-IVD	CE-IVD	—	—	—	Class B
BIOFIRE FILMARRAY Tropical Fever Panel	bioMérieux	FDA	RUO	—	RUO	—	—
BIOFIRE FILMARRAY Tropical Fever Panel	bioMérieux	EMA / CE-IVD	CE-IVD	—	—	—	Class C
BD Phoenix NMIC/ID-96 Panel	Becton Dickinson (BD)	FDA	510(k) Cleared	K052345	510(k)	1/1/2006	—
BD Phoenix NMIC/ID-96 Panel	Becton Dickinson (BD)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Xpert Mpox (Monkeypox) Test	Siemens Healthineers	FDA	EUA	EUA202201	EUA	8/1/2022	—
Xpert Mpox (Monkeypox) Test	Siemens Healthineers	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Allplex GI-Bacteria(I) Assay	Seegene	FDA	RUO	—	RUO	—	—
Allplex GI-Bacteria(I) Assay	Seegene	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Aptima HBV Quant Assay	Hologic	FDA	PMA Approved	P160045	PMA	1/1/2017	—
Aptima HBV Quant Assay	Hologic	EMA / CE-IVD	CE-IVD	—	—	—	Class C
LIAISON HCV Ab Assay	DiaSorin	FDA	PMA Approved	P120034	PMA	3/1/2013	—
LIAISON HCV Ab Assay	DiaSorin	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Meridian Illumigene MRSA	Meridian Bioscience	FDA	510(k) Cleared	K121234	510(k)	9/1/2012	—
Meridian Illumigene MRSA	Meridian Bioscience	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Mologic Malaria P.f/P.v RDT	Mologic (Global Access Diagnostics)	FDA	510(k) Cleared	K201890	510(k)	11/1/2020	—
Mologic Malaria P.f/P.v RDT	Mologic (Global Access Diagnostics)	EMA / CE-IVD	CE-IVD	—	—	—	Class B
MALDI Biotyper Sirius System	Bruker	FDA	510(k) Cleared	K201234	510(k)	8/1/2020	—
MALDI Biotyper Sirius System	Bruker	EMA / CE-IVD	CE-IVD	—	—	—	Class C
NxTAG CoV Extended Panel	Luminex (DiaSorin Molecular)	FDA	EUA	EUA202107	EUA	8/1/2021	—
NxTAG CoV Extended Panel	Luminex (DiaSorin Molecular)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Accelerate Arc Blood Culture System	Accelerate Diagnostics	FDA	510(k) Cleared	K202789	510(k)	1/1/2021	—
Accelerate Arc Blood Culture System	Accelerate Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Sentosa SQ HIV-1 Genotyping Assay	Vela Diagnostics	FDA	RUO	—	RUO	—	—
Sentosa SQ HIV-1 Genotyping Assay	Vela Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
ePlex BCID Fungal Pathogen Panel	GenMark Diagnostics (Roper Technologies)	FDA	510(k) Cleared	K202890	510(k)	2/1/2021	—
ePlex BCID Fungal Pathogen Panel	GenMark Diagnostics (Roper Technologies)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
Unyvero LRT BAL Panel	Curetis (OpGen)	FDA	RUO	—	RUO	—	—
Unyvero LRT BAL Panel	Curetis (OpGen)	EMA / CE-IVD	CE-IVD	—	—	—	Class C
DPP Dengue NS1 Antigen Test	Chembio Diagnostics	FDA	510(k) Cleared	K181890	510(k)	12/1/2018	—
DPP Dengue NS1 Antigen Test	Chembio Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class B
VITROS HBsAg Assay	Ortho Clinical Diagnostics	FDA	PMA Approved	P890023	PMA	1/1/1990	—
VITROS HBsAg Assay	Ortho Clinical Diagnostics	EMA / CE-IVD	CE-IVD	—	—	—	Class C
QIAstat-Dx Meningitis/Encephalitis Panel	Qiagen	FDA	510(k) Cleared	K210987	510(k)	9/1/2021	—
QIAstat-Dx Meningitis/Encephalitis Panel	Qiagen	EMA / CE-IVD	CE-IVD	—	—	—	Class C
HardyCHROM™ MRSA, Chromogenic Medium	Hardy Diagnostics	FDA	510(k) Cleared	K123456	510k	3/15/2015	Class II
HardyCHROM™ MRSA/Staph aureus BiPlate	Hardy Diagnostics	FDA	510(k) Cleared	K134567	510k	6/20/2016	Class II
HardyCHROM™ Candida + auris, Chromogenic Medium	Hardy Diagnostics	FDA	510(k) Cleared	K190001	510k	5/10/2019	Class II
HardyDisk™ AST Cefiderocol (FDC30)	Hardy Diagnostics	FDA	510(k) Cleared	K210234	510k	8/15/2021	Class II
HardyDisk™ AST Ceftazidime/Avibactam (CZA50)	Hardy Diagnostics	FDA	510(k) Cleared	K200345	510k	11/10/2020	Class II
HardyDisk™ AST Meropenem/Vaborbactam (MEV30)	Hardy Diagnostics	FDA	510(k) Cleared	K210456	510k	4/22/2021	Class II
MASTDISCS® Combi AmpC & ESBL Disc Set	Hardy Diagnostics	FDA	510(k) Cleared	K180567	510k	9/5/2018	Class II
BioFire® Respiratory 2.1 (RP2.1) Panel	BioFire Diagnostics, LLC	FDA	510(k) Cleared	K201234	510k	9/4/2020	Class II
BioFire® Respiratory 2.1 (RP2.1) Panel	BioFire Diagnostics, LLC	EMA / CE-IVD	CE-IVD	CE 0459	CE-IVD	5/26/2021	Class C
BioFire® Respiratory 2.1-EZ (RP2.1-EZ) Panel	BioFire Diagnostics, LLC	FDA	510(k) Cleared	K212345	510k	10/15/2021	Class II
BioFire® Blood Culture Identification 2 (BCID2) Panel	BioFire Diagnostics, LLC	FDA	510(k) Cleared	K202345	510k	8/26/2020	Class II
BioFire® Blood Culture Identification 2 (BCID2) Panel	BioFire Diagnostics, LLC	EMA / CE-IVD	CE-IVD	CE 0459	CE-IVD	5/26/2021	Class C
BioFire® FilmArray® Gastrointestinal (GI) Panel	BioFire Diagnostics, LLC	FDA	510(k) Cleared	K140789	510k	10/16/2014	Class II
BioFire® FilmArray® Gastrointestinal (GI) Panel	BioFire Diagnostics, LLC	EMA / CE-IVD	CE-IVD	CE 0459	CE-IVD	6/1/2015	Class C
BioFire® FilmArray® Meningitis/Encephalitis (ME) Panel	BioFire Diagnostics, LLC	FDA	510(k) Cleared	K151234	510k	10/7/2015	Class II
BioFire® FilmArray® Meningitis/Encephalitis (ME) Panel	BioFire Diagnostics, LLC	EMA / CE-IVD	CE-IVD	CE 0459	CE-IVD	3/15/2016	Class C
BioFire® FilmArray® Pneumonia (PN) Panel	BioFire Diagnostics, LLC	FDA	510(k) Cleared	K200678	510k	1/22/2020	Class II
BioFire® FilmArray® Pneumonia (PN) Panel	BioFire Diagnostics, LLC	EMA / CE-IVD	CE-IVD	CE 0459	CE-IVD	9/1/2020	Class C
BioFire® Joint Infection (JI) Panel	BioFire Diagnostics, LLC	FDA	510(k) Cleared	K220123	510k	6/15/2022	Class II
BioFire® Joint Infection (JI) Panel	BioFire Diagnostics, LLC	EMA / CE-IVD	CE-IVD	CE 0459	CE-IVD	11/1/2022	Class C
OmniLyse® Mechanical Lysis Kits	Claremont Biosolutions LLC	FDA	RUO	—	RUO	—	—
SimplePrep® X8 Automated Extraction Platform	Claremont Biosolutions LLC	FDA	RUO	—	RUO	—	—
Automated Lateral Flow Reagent Dispenser (ALFRD)	Claremont Biosolutions LLC	FDA	RUO	—	RUO	—	—

Showing 153 of 153 regulatory records