BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cepheid

    Reg #: 3016838963 · FEI: 3016838963 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    53
    Establishment Types
    2
    Classifications
    35

    Registration Details

    Registration Name
    Cepheid
    Registration Number
    3016838963
    FEI Number
    3016838963
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    121 N Guild Ave, 1175 S Guild Avenue
    City
    Lodi
    State
    CA
    ZIP
    95240
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250218

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

    Proprietary Names

    Xpert FII & FV Xpert TV Xpert Urine Specimen Collection kit Xpert® Hemorrhagic Fever Xpert GBS LB XC Xpert NPM1 Mutation Xpert Xpress Strep A Xpert Xpress MVP Xpert Swab Specimen Collection Kit XPERT GBS Xpert Xpress Flu/RSV Xpert HCV Xpert SA Nasal Complete Xpert Xpress CoV-2/Flu/RSV plus Xpert Xpress CoV-2 plus Xpert® Xpress CoV-2 plus Xpert Check Xpert MRSA/SA Blood Culture Xpert Bladder Cancer Monitor Xpert Xpress GBS Xpert Carba-R Xpert Mpox Xpert vanA Xpert GBS LB Xpert MRSA/SA SSTI Xpert Flu/RSV XC Xpert Flu Xpres Xpress Flu/RSV Xpert Xpress Flu Xpert C.difficile Xpert C.difficile / Epi XPERT MRSA Xpert BCR-ABL Ultra Xpert MTB/RIF Xpert Nasopharyngeal Sample Collection kit Xpert Nasal Sample Collection Kit Xpert GI Panel Xpert MTB/XDR Xpert MTB/RIF Ultra Xpert Nasopharyngeal Sample Collection Kit XPERT Xpress Flu SMARTCYCLER DX SYSTEM AND SOFTWARE Xpert Norovirus Xpert Urine Specimen Collection Kit Xpert CT/NG Xpert Vaginal/Endocervical Specimen Collection Kit Xpert Bladder Cancer Detection Xpert Breast Cancer STRAT4 Xpert MRSA/SA BC Xpert MRSA NxG Xpert MRSA /SA SSTI Xpert BCR-ABL Ultra p190 Xpert HemosIL FII & FV

    Establishment Types

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