Data / Medical devices / United States / Hologic, Inc.

Hologic, Inc.: FDA-registered device maker in San Diego, CA, United States, 32 510(k) clearances and 6 PMA approvals

Name: Hologic, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hologic, Inc. is registered with the FDA (registration 2024800) in San Diego, CA, United States. It lists 36 device types. The FDA files 32 510(k) clearances and 6 PMA approvals under its listings, the newest dated September 25, 2025. 21 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Hologic, Inc.

FDA registration number: 2024800
Address: 10210 Genetic Center Dr, San Diego, CA, United States, 92121
Owner or operator: HOLOGIC, INC. (9007676)
Roles: Manufacturer, Manufacturer for export
First device listed: January 21, 2008
Registered through: 2026
Brand names listed: APTIMA HBV QUANT ASSAY, APTIMA HPV Screening Assay, Aptima Assay Fluids Kit, Aptima Auto Detect Kit, Aptima BV Assay, Aptima BV Assay Calibrator Kit, Aptima BV Assay Controls Kit, Aptima BV assay and more

Devices it lists

Device	Product code	Class	Role	Source
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	MZP	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	PMN	2	Manufacturer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Manufacturer	accessdata.fda.gov
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices	QLT	N	Manufacturer	accessdata.fda.gov
Cytomegalovirus (Cmv) Dna Quantitative Assay	PAB	2	Manufacturer	accessdata.fda.gov
Device, Specimen Collection	LIO	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, Chlamydia	MKZ	1	Manufacturer	accessdata.fda.gov
Dna-Reagents, Neisseria	LSL	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Fetal Fibronectin	LKV	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer	accessdata.fda.gov
Fluorometer, For Clinical Use	KHO	1	Manufacturer	accessdata.fda.gov
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	PCH	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Hepatitis Viral B Dna Detection	MKT	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Herpes Simplex Virus Nucleic Acid Amplification Assay	OQO	2	Manufacturer	accessdata.fda.gov
Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	QUM	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Human Metapneumovirus (Hmpv) Rna Assay System	OEM	2	Manufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Manufacturer	accessdata.fda.gov
Kit, Rna Detection, Human Papillomavirus	OYB	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Monitor,Test,Hiv-1	MTL	3	Manufacturer for export	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	NJR	1	Manufacturer	accessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	QEP	2	Manufacturer	accessdata.fda.gov
Parainfluenza Multiplex Nucleic Acid Assay	OOU	2	Manufacturer	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer	accessdata.fda.gov
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	QQX	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
Station, Pipetting And Diluting, For Clinical Use	JQW	1	Manufacturer	accessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	NQX	2	Manufacturer for export	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Manufacturer for export	accessdata.fda.gov
Trichomonas Vaginalis Nucleic Acid Amplification Test System	OUY	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	PQA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 25, 2025	K251993	Panther Fusion GI Expanded Bacterial Assay	PCH	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
September 25, 2025	K251868	Panther Fusion GI Bacterial Assay	PCH	Substantially Equivalent	Hologic	accessdata.fda.gov
February 13, 2025	K243396	Aptima SARS-CoV-2 Assay	QQX	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
January 17, 2025	K243935	Aptima CMV Quant Assay	PAB	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
November 25, 2024	K243345	Aptima BV Assay; Aptima CV/TV Assay	PQA	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
November 15, 2024	K242465	Panther Fusion SARS-CoV-2/Flu A/B/RSV assay	QOF	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
July 24, 2024	K233352	Aptima HCV Quant Dx Assay	MZP	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
July 18, 2024	K241240	Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay	QOF	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
January 26, 2024	K231329	Aptima Neisseria gonorrhoeae Assay	LSL	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
November 16, 2023	K230451	Aptima® Chlamydia trachomatis Assay	MKZ	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
November 6, 2023	K231316	Aptima Trichomonas vaginalis Assay	OUY	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
May 16, 2023	K222736	Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay	QOF	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
May 5, 2023	K231017	Panther Fusion AdV/hMPV/RV Assay	OCC	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
May 17, 2020	K200866	Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)	QEP	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
March 23, 2020	K200436	Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit	QEP	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
May 23, 2019	K190515	Aptima Combo 2 Assay (Panther System)	QEP	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
May 23, 2019	K190452	Aptima BV Assay	PQA	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
May 16, 2019	K190472	Aptima CV/TV Assay	PQA	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
January 23, 2019	DEN180047	Aptima Mycoplasma genitalium Assay	QEP	Unknown	Hologic, Inc.	accessdata.fda.gov
December 4, 2017	K172629	Panther Fusion AdV/hMPV/RV Assay	OCC	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
October 23, 2017	K172282	Panther Fusion Paraflu Assay	OOU	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
September 26, 2017	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	OCC	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
June 15, 2017	K162673	Aptima Herpes Simplex Viruses 1 & 2 Assay	OQO	Substantially Equivalent	Hologic, Inc.	accessdata.fda.gov
October 17, 2013	K132251	APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)	LSL	Substantially Equivalent	Hologic / Gen-Probe Incorporated	accessdata.fda.gov
January 9, 2013	K122062	APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER	OUY	Substantially Equivalent	Gen-Probe, Inc.	accessdata.fda.gov
May 3, 2012	K111409	APTIMA COMBO 2 ASSAY	LSL	Substantially Equivalent	Gen-Probe, Inc.	accessdata.fda.gov
April 19, 2011	DEN110012	APTIMA TRICHOMONAS VAGINALIS ASSAY	OUY	Unknown	Gen-Probe Incorporated	accessdata.fda.gov
January 25, 2007	K063664	GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091	LSL	Substantially Equivalent	Gen-Probe, Inc.	accessdata.fda.gov
January 22, 2007	K063451	GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199	MKZ	Substantially Equivalent	Gen-Probe, Inc.	accessdata.fda.gov
August 17, 2006	K060652	TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY	LSL	Substantially Equivalent	Gen-Probe, Inc.	accessdata.fda.gov
January 23, 1991	K905762	GEN-PROBE LUMINOMETER-LEADER 450	JJQ	Substantially Equivalent	Gen-Probe, Inc.	accessdata.fda.gov
February 2, 1990	K900225	ROMCHECK SPECIMEN COLLECTION KIT	LIO	Substantially Equivalent	Adeza Biomedical	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
May 9, 2022	P210029	Aptima CMV Quant Assay	PAB	2	October 23, 2024	accessdata.fda.gov
January 23, 2018	P170025	Aptima HBV Quant Assay	MKT	23	October 7, 2025	accessdata.fda.gov
February 13, 2017	P160023	APTIMA HCV QUANT DX ASSAY	MZP	18	July 21, 2020	accessdata.fda.gov
October 12, 2012	P120007	APTIMA HPV 16 18/45 GENOTYPE ASSAY	OYB	33	February 3, 2026	accessdata.fda.gov
October 28, 2011	P100042	APTIMA HPV ASSAY	OYB	38	February 3, 2026	accessdata.fda.gov
September 21, 1995	P920048	FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)	LKV	26	August 26, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 18, 2026	98441	Class II	Ongoing	Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No	Due to product exhibiting potential to generate either invalid or false negative results.	accessdata.fda.gov
January 8, 2025	96116	Class II	Ongoing	The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnosti	Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN for the TLiIQ System which aids in assessing the risk of preterm delivery. The	accessdata.fda.gov
December 13, 2024	95948	Class II	Ongoing	Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.	Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.	accessdata.fda.gov
November 8, 2024	95731	Class II	Ongoing	Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400	SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.	accessdata.fda.gov
December 15, 2023	93593	Class II	Ongoing	PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detect	Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.	accessdata.fda.gov
September 14, 2023	94038	Class II	Ongoing	Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Prom	Use of assay along with plasma specimen may result in error code which would invalidate sample.	accessdata.fda.gov
March 18, 2022	89855	Class II	Ongoing	Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.	Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.	accessdata.fda.gov
January 27, 2022	89533	Class II	Ongoing	Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA	Failed stability specifications for reagent kits that may result in false negative test results.	accessdata.fda.gov
February 26, 2021	87557	Class II	Ongoing	Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.	There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.	accessdata.fda.gov
August 4, 2020	86248	Class II	Terminated	Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000	Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or paraflu assay.	accessdata.fda.gov
October 10, 2019	85346	Class II	Ongoing	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 Hydroxide Solution), U	Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negative results on patient samples or failed controls leading to invalid runs. This could result in incorrect results being reported and a delay i	accessdata.fda.gov
January 20, 2018	79007	Class II	Terminated	Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucle	The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator.	accessdata.fda.gov
November 29, 2017	78832	Class II	Terminated	Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200	Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX.	accessdata.fda.gov
September 15, 2017	78216	Class II	Terminated	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use	An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results.	accessdata.fda.gov
June 27, 2017	77697	Class II	Terminated	Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.	A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.	accessdata.fda.gov
March 31, 2016	73747	Class II	Terminated	CF InPlex ASR Card; Catalog Number: 95-0501.	Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.	accessdata.fda.gov
April 17, 2014	68229	Class III	Terminated	APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTI	Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens."	accessdata.fda.gov
December 15, 2009	54136	Not yet classified	Terminated	Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 0797 Specimen Collection Kit (8 pack); manufactured by Hologic, Sunnyvale, CA. Medical device for use in assessment of preterm	Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.	accessdata.fda.gov
December 30, 2008	55432	Not yet classified	Terminated	Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.	This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.	accessdata.fda.gov
May 2, 2007	44958	Not yet classified	Terminated	Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121	Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches	accessdata.fda.gov
June 11, 2004	29380	Not yet classified	Terminated	Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001	Reduced stability	accessdata.fda.gov

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Updated March 19, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.