BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    CEPHEID AB

    Reg #: 3009613136 · FEI: 3009613136 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    14

    Registration Details

    Registration Name
    CEPHEID AB
    Registration Number
    3009613136
    FEI Number
    3009613136
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rontgenvagen 5
    City
    SOLNA Stockholm
    Country
    SE

    Owner / Operator

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

    US Agent

    Business Name
    CEPHEID
    Contact Name
    Somesh Lalithraj
    Address
    904 E Caribbean Dr
    City
    Sunnyvale
    State
    CA
    ZIP
    94089
    Country
    US
    Email
    [email protected]
    Phone
    408 2427416

    Products

    Device Name Product Code
    Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test NJR
    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
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
    Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test SBP
    Culture Media, Non-Propagating Transport JSM
    Respiratory Specimen Nucleic Acid Sars-Cov-2 Test QQX
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    Real Time Nucleic Acid Amplification System OOI

    Proprietary Names

    Xpert Xpress GBS Xpert Urine Specimen Collection Kit Xpert Swab Specimen Collection Kit Xpert CT/NG Xpert Vaginal/Endocervical Specimen Collection Kit Xpert Xpress Flu Xpert GI Panel Xpert Xpress CoV-2/Flu/RSV plus Xpert Xpress Strep A Xpert HCV Xpert Xpress Flu/RSV Xpert® Xpress CoV-2 plus Xpert Nasal Sample Collection Kit Xpert Nasopharyngeal Sample Collection Kit XPERT Xpress Flu Xpert Nasopharyngeal Sample Collection kit Xpert Norovirus Xpert Xpress CoV-2 plus Xpert GBS LB XC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)