BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CEPHEID

    Reg #: 3004530258 · FEI: 3004530258 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    67
    Establishment Types
    3
    Classifications
    36

    Registration Details

    Registration Name
    CEPHEID
    Registration Number
    3004530258
    FEI Number
    3004530258
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    904 CARIBBEAN DRIVE
    City
    Sunnyvale
    State
    CA
    ZIP
    94089
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160901

    Owner / Operator

    Firm Name
    CEPHEID
    Operator Number
    9062742
    Address
    904 CARIBBEAN DRIVE, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94089
    Country
    US
    Correspondent
    Somesh Lalithraj

    Products

    Device Name Product Code
    Real Time Nucleic Acid Amplification System OOI
    System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen POC
    Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test NJR
    Test, Factor Ii G20210a Mutations, Genomic Dna Pcr NPR
    Test, Factor V Leiden Mutations, Genomic Dna Pcr NPQ
    System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen PEU
    Clinical Sample Concentrator JJH
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH
    System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen NQX
    Dna-Reagents, Neisseria LSL
    Dna Probe, Nucleic Acid Amplification, Chlamydia MKZ
    C. Difficile Nucleic Acid Amplification Test Assay OMN
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Respiratory Specimen Nucleic Acid Sars-Cov-2 Test QQX
    Multi-Analyte Controls Unassayed OHQ
    Assay, Enterovirus Nucleic Acid OAI
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
    Bcr/Abl1 Monitoring Test OYX
    System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony PMY
    Culture Media, Non-Propagating Transport JSM
    System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species NIJ
    Somatic Gene Mutation Detection System OWD
    Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies QDC
    Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System PQA
    Trichomonas Vaginalis Nucleic Acid Amplification Test System OUY
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    System, Test, Tumor Marker, Monitoring, Bladder MMW
    Assay, Direct, Nucleic Acid Amplification, Influenza Virus NIA
    Reagents, Clostridium Difficile Toxin LLH
    Reagents, Monkeypox Virus Nucleic Acid. QTP
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    System, Test, Tumor Marker, For Detection Of Bladder Cancer NAH
    Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test SBP
    Instrumentation For Clinical Multiplex Test Systems NSU
    Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections QEP
    Microbial Nucleic Acid Storage And Stabilization Device QBD

    Proprietary Names

    Xpert Carba-R GeneXpert Edge System (For Export Only) GeneXpert Edge X SMARTCYCLER DX SYSTEM AND SOFTWARE Xpert FII & FV Xpert MTB/RIF Xpert MTB/XDR Xpert MTB/RIF Ultra Xpert FFPE Lysis Kit Xpert GI Panel Xpert MRSA/SA Blood Culture Xpert CT/NG Xpert MRSA/SA BC Xpert SA Nasal Complete Xpert MRSA NxG Xpert MRSA /SA SSTI Xpert HemosIL FII & FV Xpert CT XPERT GBS Xpert C.difficile Xpert C.difficile / Epi Xpert Nasopharyngeal Sample Collection kit Xpert Xpress Flu Xpert Nasal Sample Collection Kit Xpert Check XPERT EV Xpert Xpress Strep A Xpert BCR-ABL Ultra Xpert BCR-ABL Ultra p190 Xpert Xpress Flu/RSV GeneXpert DX systems GeneXpert Infinity-48s system GeneXpert Infinity-80 System GeneXpert Xpress System GeneXpert system with Touchscreen GeneXpert Infinity Systems Xpert Nasopharyngeal Sample Collection Kit XPERT Xpress Flu Xpert vanA Xpert Breast Cancer STRAT4 Xpert GBS LB XC Xpert NPM1 Mutation Xpert Swab Specimen Collection Kit Xpert Xpress MVP Xpert TV Xpert Urine Specimen Collection kit Xpert Xpress CoV-2/Flu/RSV plus Xpert GBS LB Xpert Bladder Cancer Monitor Xpert MRSA/SA SSTI Xpert Xpress Step A Xpert Flu/RSV XC Xpert Flu Xpres Xpress Flu/RSV Xpert® Xpress CoV-2 plus Xpert Mpox Xpert Xpress SARS-CoV-2 Xpert Xpress CoV-2 plus Xpert Xpress SARS-CoV-2/Flu/RSV Xpert Bladder Cancer Detection Xpert HCV Xpert Norovirus Xpert Xpress GBS XPERT MRSA Xpert Vaginal/Endocervical Specimen Collection Kit Xpert Urine Specimen Collection Kit Xpert GBS

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Develop Specifications But Do Not Manufacture At This Facility