BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SA SCIENTIFIC, LTD

    Reg #: 1645225 · FEI: 1000118544 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    12

    Registration Details

    Registration Name
    SA SCIENTIFIC, LTD
    Registration Number
    1645225
    FEI Number
    1000118544
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4919 GOLDEN QUAIL
    City
    SAN ANTONIO
    State
    TX
    ZIP
    78240
    Country
    US

    Regulatory Submissions

    510(k) Number
    K944785

    Owner / Operator

    Firm Name
    SA Scientific, Ltd
    Operator Number
    9004843
    Address
    4919 Golden Quail
    City
    San Antonio
    State
    TX
    Postal Code
    78240
    Country
    US
    Correspondent
    Mathiri Mani

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Devices Detecting Influenza A, B, And C Virus Antigens PSZ
    Legionella, Spp., Elisa MJH
    Visual, Pregnancy Hcg, Prescription Use JHI
    Test, Sickle Cell GHM
    Antigens, Cf (Including Cf Control), Reovirus 1-3 GQB
    Candida Spp., Direct Antigen, Id LRF
    Antistreptolysin - Titer/Streptolysin O Reagent GTQ
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus GQG
    Antigens, All Groups, Streptococcus Spp. GTY
    Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD

    Proprietary Names

    SAS SAS FluAlert A&B Test SAS Legionella Test SAS Influenza B Test SAS ROTA TEST SAS CANDIDA ANTISERA SAS ASO-LATEX SAS Influenza A Test SAS RSV TEST SAS Strep Alert SAS ADENO TEST

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)