BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hologic, Inc.

    Reg #: 2024800 · FEI: 2024800 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    174
    Establishment Types
    2
    Classifications
    36

    Registration Details

    Registration Name
    Hologic, Inc.
    Registration Number
    2024800
    FEI Number
    2024800
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    10210 Genetic Center Dr
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN180047
    PMA Number
    P100042

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

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

    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 BV assay Aptima BV Assay Calibrator Kit Aptima BV Assay Controls Kit Rapid fFN Specimen Collection Kit Aptima HCV Quant Dx Assay APTIMA HBV QUANT ASSAY Aptima HBV Quant Controls Kit Aptima HBV Quant Calibrator Kit Aptima HBV Quant Target Enhancer Reagent Box 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 Combo 2 Assay (Throat and Rectal Swab Specimen Claims) 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 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 Trichomonas Vaginalis Assay Aptima Trichomonas Vaginalis Controls Kit Panther Fusion GI Expanded Bacterial Assay Panther Fusion GI Expanded Bacterial Assay Cartridge 96 Tests Panther Fusion GI Expanded Bacterial Assay Controls Aptima HBV Quant Assay Tigris DTS System Panther System Panther System, Continuous Fluid and Waste 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 Tomcat Instrument Aptima Transfer Solution Aptima Combo 2 Assay on Panther system Aptima Combo 2 Assay on Tigris System Aptima HIV-1 Quant Dx Assay Calibrator Aptima HIV-1 Quant Dx Assay Controls Kit Aptima BV Assay Aptima CV/TV Assay Rapid fFN 10Q System PeriLynx System PTDCheck Aptima Chlamydia trachomatis Assay SysCheck Aptima Trichomonas Vaginalis Assay on Panther system Aptima Trichomonas Vaginalis Assay on Tigris system Aptima Combo 2 Ready Made Reagent Assay Kit Aptima Trichomonas Vaginalis Ready Made Reagent Assay Kit Panther Fusion Extraction Reagents-X Panther Fusion Extraction Reagents-S Panther Fusion Extraction Reagents-B Aptima Chlamydia Trachomatis Assay Panther Fusion Flu A/B/RSV Assay Panther Fusion Specimen Lysis Tubes Panther Fusion Reconstitution Buffer I 1920 Tests Panther Fusion Internal Control-S 960 Tests Panther Fusion Elution Buffer 2400 Tests Panther Fusion Flu A/B/RSV Assay Cartridges 96 Tests Panther Fusion Flu A/B/RSV Assay Controls Panther Fusion Oil 1920 Tests Panther Fusion Extraction Reagent-S 960 Tests Aptima Urine Specimen Collection Kit for Male and Female Urine Specimens Aptima Unisex Specimen Collection Kit for Endocervical and Male Urethral Swab Specimens Aptima Auto Detect Kit Aptima Specimen Transfer Kit Aptima Multitest Swab Collection Kit Aptima Assay Fluids Kit Aptima Urine Specimen Transport Tubes

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only