FDA.report

Hologic, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12218551221855Hologic, Inc.1N2026-01-014 Navigator Rd LONDONDERRY NH US 03053
12227801000120743HOLOGIC, INC.1Y2026-01-01250 Campus Dr Marlborough MA US 01752
20248002024800Hologic, Inc.1Y2026-01-0110210 Genetic Center Dr SAN DIEGO CA US 92121
30054962663005496266HOLOGIC, INC.1N2026-01-01600 Technology Drive Newark DE US 19702
30063300303006330030Hologic, Inc.1N2026-01-01445 Simarano Drive Marlborough MA US 01752
12209841220984Hologic, Inc.1N2020-04-2536 APPLE RIDGE RD. DANBURY CT US 06810
29398521000124200Hologic, Inc.1N2020-04-251240 ELKO DRIVE SUNNYVALE CA US 94089

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3223322040648580P970058M1000 IMAGECHECKERMYN 1998-06-26
141202040648580P970058M1000 IMAGECHECKERMYN 1998-06-26
825501822706989P950039THINPREP(R) PROCESSOR, MODEL TP 2000MKQ1996-05-20
825501822706989P950039THINPREP(R) PROCESSOR, MODEL TP 2000MKQ1996-05-20
825481822706989P950039THINPREP(R) PROCESSOR, MODEL TP 2000MKQ1996-05-20
825461822706989P950039THINPREP(R) PROCESSOR, MODEL TP 2000MKQ1996-05-20
825461822706989P950039THINPREP(R) PROCESSOR, MODEL TP 2000MKQ1996-05-20
1471721809426043P940034GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)MWA1995-12-15
1471721414778586P920048FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)LKV1995-09-21
825511414778586P920048FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)LKV1995-09-21
825481414778586P920048FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)LKV1995-09-21
1471721668990975P210029Aptima CMV Quant AssayPAB 2022-05-09
1471721172428899P170025Aptima HBV Quant AssayMKT2018-01-23
1471721232477131P160023APTIMA HCV QUANT DX ASSAYMZP2017-02-13
1471721920231708P120007APTIMA HPV 16 18/45 GENOTYPE ASSAYOYB2012-10-12
1471721090241396P100042APTIMA HPV ASSAYOYB2011-10-28
1471721010601805P100033PROGENSA PCA3 ASSAYOYM2012-02-13
1471721787124509P080015CERVISTA HPV 16/18MAQ2009-03-12
825461938260113P080014CERVISTA HPV HR AND GENFIND DNA EXTRACTION KITMAQ2009-03-12
825481938260113P080014CERVISTA HPV HR AND GENFIND DNA EXTRACTION KITMAQ2009-03-12
1471721938260113P080014CERVISTA HPV HR AND GENFIND DNA EXTRACTION KITMAQ2009-03-12
3223321819363063P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE2011-02-11
141201819363063P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE2011-02-11
1471721182706925P020011VERSANT HCV RNA QUALITATIVE ASSAYMZP2002-11-07
825482016712891P020002THINPREP (R) IMAGING SYSTEMMNM2003-06-06
825462016712891P020002THINPREP (R) IMAGING SYSTEMMNM2003-06-06
141201686514750P010025LORAD DIGITAL BREAST IMAGERMUE2002-03-15
3223321686514750P010025LORAD DIGITAL BREAST IMAGERMUE2002-03-15
825461081561366P010013NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEMMNB2001-09-28
825481081561366P010013NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEMMNB2001-09-28
1471721037575530K974572GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820MDK1998-09-24
1471721126316087K940979GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORRLSL1994-10-31
1471721457486303K924715GEN-PROBE DIRECT GROUP A STREPTOCOCUS TESTMDK1994-03-11
1471721725186074K921435ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURELQF1992-07-23
1471721566719290K905762GEN-PROBE LUMINOMETER-LEADER 450JJQ1991-01-23
1471721068600755K904463ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TESTLQF1990-11-13
1471721042140239K904047ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.MDF1990-10-02
1471721119715267K903556ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TESTMDE1990-10-02
1471721424879742K903201ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TESTMDC1990-09-12
1471721835041759K902908ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.MCT1990-08-06
1471721849612737K902213ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.MCS1990-08-06
1471721855430336K901397ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.MCC1990-06-20
1471721756165192K900225ROMCHECK SPECIMEN COLLECTION KITLIO1990-02-02
825511756165192K900225ROMCHECK SPECIMEN COLLECTION KITLIO1990-02-02
1471721294209617K897077ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURELQF1990-08-23
1471721734339521K896859ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TESTMBT1990-02-01
1471721345933894K896493ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TESTLQF1990-04-11
1471721180035892K896492ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TESTLQF1990-04-16
1471721925956558K895583ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.LSL1989-11-14
1471721787985127K894711ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.GTZ1989-11-14
1471721870443865K892216GEN-PROBE PACE SYSTEM URINE SCREENJXA1989-09-15
1471721024872819K870422GEN-PROBE BETA-LACTAMASE TEST KITJTO1987-04-21
1471721350553225K860574GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEMLQG1986-07-03
1471721450475965K851271LEGIONELLA CULTURE CONFIRMATIN KITGRO1985-07-08
1471721672089001K251993Panther Fusion GI Expanded Bacterial AssayPCH2025-09-25
1471721775029324K251868Panther Fusion GI Bacterial AssayPCH2025-09-25
1471721393807055K243935Aptima CMV Quant AssayPAB2025-01-17
1471721388245826K243396Aptima SARS-CoV-2 AssayQQX2025-02-13
1471721600047419K243345Aptima BV Assay; Aptima CV/TV AssayPQA2024-11-25
3223321838593481K243341Genius AI Detection 2.0QDQ2025-07-31
1471721903357787K242465Panther Fusion SARS-CoV-2/Flu A/B/RSV assayQOF2024-11-15
1471721969145069K241240Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF2024-07-18
825481603453877K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)HIG2024-07-25
825461603453877K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)HIG2024-07-25
1471721386497909K233352Aptima HCV Quant Dx AssayMZP2024-07-24
1471721652777373K231329Aptima Neisseria gonorrhoeae AssayLSL2024-01-26
1471721568622140K231316Aptima Trichomonas vaginalis AssayOUY2023-11-06
1471722045271054K231017Panther Fusion AdV/hMPV/RV AssayOCC2023-05-05
1471721003469928K230451Aptima® Chlamydia trachomatis AssayMKZ2023-11-16
3223321033952506K230096Genius AI Detection 2.0 with CC-MLO CorrelationQDQ2023-05-23
1471721173238648K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayQOF2023-05-16
3223321268906682K221449Genius AI Detection 2.0QDQ2022-10-06
825461259920593K211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)GEI2021-09-07
825462024439993K203640CoolSeal RevealGEI2021-05-06
3223321095290126K202294Affirm Contrast BiopsyIZH2020-10-05
825461085255110K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20GEI2020-10-06
3223321183317565K201019Genius AI DetectionQDQ2020-11-18
1471721845674297K200866Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)QEP2020-05-17
1471721913217545K200436Aptima 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 kitQEP2020-03-23
825461290740641K192371BioZorb SP MarkerNEU2019-09-26
825461942002579K191281Omni Hysteroscope, Omni Lok cervical sealHIH2019-08-29
825461444738216K190813CrossBay Cervical Dilator Catheter SystemPON2019-08-23
3223321482153036K190694Unifi Workspace v1.0.0LLZ2019-07-11
141201482153036K190694Unifi Workspace v1.0.0LLZ2019-07-11
825481296470871K190678TempSureGEI2019-07-24
1471721321949227K190515Aptima Combo 2 Assay (Panther System)QEP2019-05-23
1471721629563572K190472Aptima CV/TV AssayPQA2019-05-16
1471721523487084K190452Aptima BV AssayPQA2019-05-23
3223321015348947K183142PathVisionXLMWP2019-03-14
3223322019704017K182727Trident HD Specimen Radiography SystemMWP2019-01-10
141202019704017K182727Trident HD Specimen Radiography SystemMWP2019-01-10
825481952747785K182365TempSure SystemGEI2018-10-24
825461045265839K182052Omni Instrument TrayKCT2019-02-26
825461460346830K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHIH2018-12-06
825462061981158K181974MyoSure XL Tissue Removal Device for FluentHIH2018-08-23
825461267677027K181124Acessa ProVu SystemHFG2018-09-28
825481267677027K181124Acessa ProVu SystemHFG2018-09-28
825481677731182K180825Fluent Fluid Management SystemHIG2018-08-03
825461677731182K180825Fluent Fluid Management SystemHIG2018-08-03
825461014821240K180233Eviva Stereotactic Guided Breast Biopsy SystemKNW2018-04-10
825461604967866K173901MyoSure MANUAL Tissue Removal DeviceHIH2018-05-08
1471721984419248K172629Panther Fusion AdV/hMPV/RV AssayOCC2017-12-04
825461000257084K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH2017-09-20
1471721364958247K172282Panther Fusion Paraflu AssayOOU2017-10-23
1471721835677155K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis TubesOCC2017-09-26
825481044636491K171262TempSureGEI2017-09-22
141201775146042K163623QuantraLLZ2017-10-20
3223321775146042K163623QuantraLLZ2017-10-20
3223322011353142K163052Brevera Biopsy System with Corlumina Imaging TechnologyKNW2017-03-29
825462011353142K163052Brevera Biopsy System with Corlumina Imaging TechnologyKNW2017-03-29
1471721724624678K162673Aptima Herpes Simplex Viruses 1 & 2 AssayOQO2017-06-15
141201332125062K161575Affirm Lateral Arm Upright Biopsy AccessoryIZH2016-08-10
3223321332125062K161575Affirm Lateral Arm Upright Biopsy AccessoryIZH2016-08-10
141201017626099K153486Affirm Prone Biopsy SystemIZH2016-04-01
3223321017626099K153486Affirm Prone Biopsy SystemIZH2016-04-01
825461219927638K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH2015-11-13
825481219927638K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHIH2015-11-13
825461459820442K152070BioZorb LP MarkerNEU2015-08-26
825461543774113K150169Sertera Biopsy DeviceKNW2015-08-14
825462062679005K143484BioZorb MarkerNEU2015-06-29

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HIH272019-08-29
IZH212020-10-05
LLZ152019-07-11
NEU132019-09-26
JAQ122009-08-27
KNW92018-04-10
GEI82021-09-07
LSL72024-01-26
MWP72019-03-14
OCC62023-05-05
HIG52024-07-25
MKQ51996-05-20
LQF51992-07-23
QDQ42025-07-31
OUY42023-11-06
QEP42020-05-17
MUE42013-01-29
MAQ42009-03-12
KGI42008-03-28
PCH32025-09-25
PQA32024-11-25
QOF32024-11-15
MZP32024-07-24
MKZ32023-11-16
KCT32019-02-26
OXO32012-04-06
LKV31995-09-21
QYV22024-01-31
HFG22018-09-28
OOU22017-10-23
OYB22012-10-12
OMM22011-05-13
OTE22011-02-11
GEH22008-02-07
IYX22006-09-13
JAA22005-05-13
MNM22003-06-06
MNB22001-09-28
MDK21998-09-24
MYN 21998-06-26

PMA

NovaSure Impedance Controlled Endometrial Ablation System

2022-12-01

HOLOGIC, INC.250 Campus Drivemarlborough, MA 01752 PMA NumberP010013 Supplement NumberS089 Date Received11/02/2022 Decision Date12/01/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Typespecial (immediate Track) Supplement Reason ...

NovaSure Impedance Controlled Endometrial Ablation System

2022-11-02

HOLOGIC, INC.250 Campus Drivemarlborough, MA 01752 PMA NumberP010013 Supplement NumberS088 Date Received10/31/2022 Decision Date11/02/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Chan...

NovaSure Impedance Controlled Endometrial Ablation System

2022-08-04

HOLOGIC, INC.250 Campus Drivemarlborough, MA 01752 PMA NumberP010013 Supplement NumberS087 Date Received08/03/2022 Decision Date08/04/2022 Product Code MNB  Advisory Committee Obstetrics/Gynecology Supplement Type30-day Notice Supplement Reason Process Chan...

Aptima CMV Quant Assay

2022-07-20

Hologic, Inc.10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP210029 Supplement NumberS001 Date Received06/16/2022 Decision Date07/20/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Chang...

Aptima CMV Quant Assay

2022-05-09

Hologic, Inc.10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP210029 Date Received07/26/2021 Decision Date05/09/2022 Product Code PAB  Advisory Committee Microbiology Expedited Review Granted? No

Rapid fFN for the TLiIQ System

2022-05-09

HOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS023 Date Received04/29/2022 Decision Date05/09/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufactu...

Rapid fFN for the TLiIQ System

2022-04-13

HOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS022 Date Received03/31/2022 Decision Date04/13/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufactu...

Rapid fFN for the TLiIQ System

2022-02-28

HOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS021 Date Received02/14/2022 Decision Date02/28/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufactu...

PMN

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