Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2024800

FEI Number

2024800

Entity Name

Hologic, Inc.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

10210 Genetic Center Dr, SAN DIEGO, CA 92121, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

HOLOGIC, INC. (Owner Number: 9007676)

Owner / Operator Contact Address

250 Campus Drive, --, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aptima Mycoplasma genitalium Assay Aptima Mycoplasma genitalium Calibrators Kit Aptima Trichomonas vaginalis Ready Made Reagent Assay Kit Aptima Trichomonas vaginalis Controls Kit Aptima Trichomonas vaginalis Assay APTIMA HPV Screening Assay Aptima HPV Controls Box Aptima HPV Calibrators Box Aptima HSV 1 & 2 assay Aptima HSV 1 & 2 Controls Kit Aptima HCV Quant Dx assay Aptima HCV Quant Dx Calibrator Kit Aptima HCV Quant Dx Controls Kit Panther Fusion GBS Assay Panther Fusion Extraction Reagent-X 960 Tests Panther Fusion GBS Assay Controls Panther Fusion Internal Control-X 960 Tests Panther Fusion GBS Assay Cartridges 96 Tests Aptima HPV 16 18/45 Genotype Assay Aptima HPV 16 18/45 Genotype Assay Calibrators Box Panther Fusion MRSA Assay Cartridges 96 Tests Panther Fusion MRSA Assay Controls Panther Fusion Reconstitution Buffer II 1920 Tests Panther Fusion MRSA Assay Panther Fusion AdV/hMPV/RV Assay Panther Fusion AdV/hMPV/RV Assay Controls Panther Fusion AdV/hMPV/RV Assay Cartridges 96 Tests RNA IC Primer RNA IC Probe DNA IC Primer DNA IC Probe VZV Primers BKV Probe VZV Probe GAS Probe BKV Primers EBV Primers CMV Probe EBV Probe GAS Primers CMV Primers Coronavirus Probes Coronavirus Primers Mycoplasma genitalium Macrolide Resistance Probes Mycoplasma genitalium Macrolide Resistance Primers Neisseria gonorrhoeae Resistance Probe Neisseria gonorrhoeae Resistance Primers Aptima Cervical Specimen Collection and Transport Kit Aptima HIV-1 Quant Dx Assay Aptima Specimen Diluent Kit Aptima Specimen Diluent Aptima HIV-1 Quant Dx Calibrator Kit Aptima HIV-1 Quant Dx Controls Kit Vortexer Aptima CV/TV Assay Calibrator Kit Aptima CV/TV assay Aptima CV/TV Assay Controls Kit Panther Fusion GI Bacterial Assay Cartridge 96 Tests Panther Fusion GI Bacterial Assay Controls Panther Fusion GI Bacterial Assay Panther Fusion Internal Control-B Panther Fusion Extraction Reagent-B Aptima DBS Extraction Buffer Aptima SARS-CoV-2/Flu Controls Kit Aptima SARS-CoV-2/Flu Assay Aptima SARS-CoV-2 Controls Kit Panther Fusion SARS-CoV-2 Assay Controls Aptima SARS-CoV-2 Assay Panther Fusion SARS-CoV-2 Assay PPR Solution Hologic Specimen Lysis Tubes Hologic Direct Load Capture Cap Collection Kit - CLASSIQSwabs Hologic Direct Load Capture Cap Collection Kit - FLOQSwabs Hologic Direct Load Tube Collection Kit Panther Fusion System Panther Fusion Paraflu Assay Panther Fusion Paraflu Assay Controls Panther Fusion Paraflu Assay Cartridges 96 Tests Aptima Controls Kit Aptima Neisseria gonorrhoeae Assay Aptima SARS-CoV-2 Assay Aptima SARS-CoV-2 Controls Kit Aptima BV assay Aptima BV Assay Calibrator Kit Aptima BV Assay Controls Kit Rapid fFN Specimen Collection Kit Aptima HCV Quant Dx Controls Kit Aptima HCV Quant Dx Assay Aptima HCV Quant Dx Calibrator Kit Aptima Specimen Diluent APTIMA HBV QUANT ASSAY Aptima HBV Quant Controls Kit Aptima HBV Quant Calibrator Kit Aptima HBV Quant Target Enhancer Reagent Box Aptima Specimen Diluent Aptima Controls Kit Aptima Combo 2 Assay Epstein-Barr Virus IVT Control Epstein-Barr Virus Plasmid Control Group A Streptococcus Plasmid Control BK Virus Plasmid Control Varicella Zoster Virus IVT Control Cytomegalovirus IVT Control Cytomegalovirus Plasmid Control Varicella Zoster Virus Plasmid Control BK Virus IVT Control Internal Control-B Mycoplasma genitalium Controls Neisseria gonorrhoeae Resistance C272T IVT Control Neisseria gonorrhoeae IVT WT Control INFINITE F200 MICROPLATE FLUORESCENCE READER Aptima HIV-1 Quant Dx Calibrator Kit Aptima HIV-1 Quant Dx Controls Kit Aptima Specimen Diluent Kit Aptima Specimen Diluent Aptima HIV-1 Quant Dx Assay Aptima Combo 2 Assay (Throat and Rectal Swab Specimen Claims) Aptima Controls Kit Aptima HIV-1 Quant Dx Assay Aptima HIV-1 Quant Dx Calibrator Kit Aptima HIV-1 Quant Dx Controls Kit Aptima Specimen Diluent Aptima Specimen Diluent Kit Panther Fusion AdV/hMPV/RV Assay Panther Fusion AdV/hMPV/RV Assay Controls Panther Fusion AdV/hMPV/RV Assay Cartridges 96 Tests Aptima SARS-CoV-2/Flu Assay Aptima SARS-CoV-2/Flu Controls Kit Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Cartridges 96 Tests Hologic RespDirect Collection Kit Panther Fusion SARS CoV-2/Flu A/B/RSV Assay Panther Fusion SARS CoV-2/Flu A/B/RSV Assay Controls TLiIQ Fetal Fibronectin Test Panther Fusion SARS-CoV-2/Flu A/B/RSV assay Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Cartridges 96 Tests Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Controls Aptima CMV Quant Controls Kit Aptima CMV Quant Calibrator Kit Aptima CMV Quant Assay Aptima CMV Quant Target Enhancer Reagent Box Aptima Neisseria Gonorrhoeae Assay Aptima Controls Kit Aptima Trichomonas Vaginalis Assay Aptima Trichomonas Vaginalis Controls Kit Panther Fusion GI Expanded Bacterial Assay Panther Fusion Internal Control-B Panther Fusion GI Expanded Bacterial Assay Cartridge 96 Tests Panther Fusion Extraction Reagent-B Panther Fusion GI Expanded Bacterial Assay Controls Aptima HBV Quant Assay Aptima HBV Quant Target Enhancer Reagent Box Aptima Specimen Diluent Kit Aptima HBV Quant Controls Kit Aptima Specimen Diluent Aptima HBV Quant Calibrator Kit Aptima HIV-1 Quant Dx Assay Aptima HIV-1 Quant Dx Calibrator Kit Aptima Specimen Diluent Kit Aptima HIV-1 Quant Dx Controls Kit Aptima Specimen Diluent Tigris DTS System Panther System Panther System, Continuous Fluid and Waste Panther Fusion System Procleix Panther System Cleavase Enzyme Solution Aptima General Purpose Reagents Aptima Real-Time General Purpose Reagents Open Access DNA/RNA Enzyme Open Access Diluent Additive Specimen Transport Medium Blood Transport Medium Urine Transport Medium Aptima Whole Blood Diluent Oil Reagent Aptima HPV Assay Aptima HPV Calibrators Box Aptima CMV Quant Assay Aptima CMV Quant Controls Kit Aptima CMV Quant Target Enhancer Reagent Box Aptima CMV Quant Calibrator Kit Tomcat Instrument Aptima Transfer Solution Aptima Combo 2 Assay on Panther system Aptima Combo 2 Assay on Tigris System Aptima Controls Kit Panther Fusion SARS-CoV-2/Flu A/B/RSV assay Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Cartridges 96 Tests Hologic RespDirect Collection Kit Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Controls Aptima Trichomonas Vaginalis Assay Aptima Trichomonas Vaginalis Controls Kit Aptima Specimen Diluent Aptima Specimen Diluent Kit Aptima HIV-1 Quant Dx Assay Aptima HIV-1 Quant Dx Assay Calibrator Aptima HIV-1 Quant Dx Assay Controls Kit Aptima BV Assay Aptima CV/TV Assay Calibrator Kit Aptima CV/TV Assay Controls Kit Aptima BV Assay Calibrator Kit Aptima CV/TV Assay Aptima BV Assay Controls Kit Aptima Combo 2 Assay Aptima Controls Kit Panther Fusion System Aptima HCV Quant Dx Assay Aptima HCV Quant Dx Controls Kit Aptima Specimen Diluent Aptima Specimen Diluent Kit Aptima HCV Quant Dx Calibrator Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2019-01-23
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2025-01-10
OYB	Kit, Rna Detection, Human Papillomavirus	Unknown	Class 3	N/A	2012-10-29
OQO	Herpes Simplex Virus Nucleic Acid Amplification Assay	Microbiology	Class 2	866.3305	2017-06-16
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology	Class 2	866.3170	2017-02-13
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	Microbiology	Class 1	866.3740	2018-06-13
OYB	Kit, Rna Detection, Human Papillomavirus	Unknown	Class 3	N/A	2015-04-07
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2024-12-06
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2017-12-05
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2017-12-05
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2017-12-05
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2010-07-12
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2016-04-12
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2016-03-31
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2008-04-11
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2019-05-31
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2019-05-31
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2025-09-29
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2025-09-29
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2010-06-01
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2024-12-17
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-05-05
OOU	Parainfluenza Multiplex Nucleic Acid Assay	Microbiology	Class 2	866.3980	2017-10-30
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2017-10-30
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2025-01-10
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2025-01-10
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2025-02-21
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2025-02-21
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2019-05-31
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2019-05-31
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2019-05-31
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2009-08-27
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology	Class 2	866.3170	2024-12-17
MKT	Hepatitis Viral B Dna Detection	Microbiology	Class 2	866.3174	2018-01-23
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2023-08-02
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2023-08-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-10-31
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2012-12-10
QUM	Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	Microbiology	Class 2	866.3958	2025-09-30
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2019-05-31
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2019-05-31
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2019-05-31
QUM	Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	Microbiology	Class 2	866.3958	2017-01-11
OCC	Respiratory Virus Panel Nucleic Acid Assay System	Microbiology	Class 2	866.3980	2025-01-10
OEM	Human Metapneumovirus (Hmpv) Rna Assay System	Microbiology	Class 2	866.3980	2025-01-10
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2025-01-10
QLT	Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices	Unknown	Class N	N/A	2020-12-21
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-05-24
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2023-05-24
LKV	Enzyme Immunoassay, Fetal Fibronectin	Unknown	Class 3	N/A	2008-01-21
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-11-21
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2024-11-21
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Microbiology	Class 2	866.3180	2025-01-24
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2015-04-07
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2024-12-06
PCH	Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Microbiology	Class 2	866.3990	2025-09-29
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2025-09-29
MKT	Hepatitis Viral B Dna Detection	Microbiology	Class 2	866.3174	2020-09-24
MTL	Monitor,Test,Hiv-1	Unknown	Class 3	N/A	2016-03-31
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2018-09-10
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2008-04-17
OYB	Kit, Rna Detection, Human Papillomavirus	Unknown	Class 3	N/A	2025-08-19
PAB	Cytomegalovirus (Cmv) Dna Quantitative Assay	Microbiology	Class 2	866.3180	2022-05-13
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2009-12-23
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2024-12-06
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2020-05-19
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2020-05-19
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2020-05-19
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2024-11-21
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-11-21
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2015-04-07
QUM	Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	Microbiology	Class 2	866.3958	2024-11-21
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2024-12-11
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2024-12-11
PQA	Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	Microbiology	Class 2	866.3975	2024-12-11
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2015-04-07
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2015-04-07
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2015-04-07
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2017-09-25
MZP	Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	Microbiology	Class 2	866.3170	2020-09-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HOLOGIC, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013649990	HEALTH BEACONS, INC.	Marlborough, MA, US
3012644426	ENDOMAGNETICS LTD	Cambridge Cambridgeshire, GB
3005875675	GYNESONICS, INC.	REDWOOD CITY, CA, US
3006330030	Hologic, Inc.	Marlborough, MA, US
3010377594	BOLDER SURGICAL, LLC	LOUISVILLE, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Z-0042-2025	Luminex Molecular Diagnostics Inc	2	NxTAG Respiratory Pathogen Panel, REF: I051C0447
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024800. Last updated year: 2026. Please use registration number 2024800 when referencing this establishment in official correspondence.