BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    TECHNO-PATH MANUFACTURING LTD.

    Reg #: 3008156187 · FEI: 3008156187 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    87
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    TECHNO-PATH MANUFACTURING LTD.
    Registration Number
    3008156187
    FEI Number
    3008156187
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Fort Henry Business Park
    City
    Ballina Tipperary
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K131992

    Owner / Operator

    Firm Name
    Techno-path Manufacturing Ltd.
    Operator Number
    10030933
    Address
    Fort Henry Business Park
    City
    Ballina
    State
    Tipperary
    Postal Code
    V94FF1P
    Country
    IE

    US Agent

    Business Name
    LGC Clinical Diagnostics, INC.
    Contact Name
    Wais Osmani
    Address
    37 Birch St
    City
    Milford
    State
    MA
    ZIP
    01757
    Country
    US
    Email
    [email protected]
    Phone
    774 5735689

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Multi-Analyte Controls Unassayed OHQ
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Drug Mixture Control Materials DIF
    Assayed Quality Control Material For Clinical Microbiology Assays QCH

    Proprietary Names

    Multichem P 05P81 Multichem P, SP41PA, Multichem AE AE621X, AE622X, AE623X Multichem ID-SeroNeg SR100N & SR100MN Multichem AE Unassayed Bilevel -AE600X, AE601X, AE602X, Trilevel - AE610X, AE611X, AE612X,AE613X Multichem CSF Unassayed CF100X, CF101X, CF102X Multichem S Plus CH104CRP, CH105CRP Multichem IA Plus IA320X Multichem S Plus Unassayed Alinity 08P87-10/11/12 Multichem ID-COVID19 G CVG200P Multichem hsTn Unassayed HS301X/MX Multichem AMH AM501X, AM502X, AM503X Multichem ID-B SR103B Multichem ID-COVID19 G CVG100P Multichem IA Unassayed IA300X, IA301X, IA302X, IA303X Multichem ID-COVID19 G CVG300P Multichem WBT Unassayed WB000X Multichem U Unassayed - UC201X, UC202X Multichem S Unassayed CH101x/102X/103X/101X5/102X5/103X5 Multichem D-Dimer Unassayed DM900X, DM900MX, DM901X, DM902X Multichem SP Unassayed, SP101, SP102 Multichem P Unassayed SP40PX Multichem IA Plus Unassayed - IA315X, IA315MX, IA316X, IA317X, IA318X Multichem IA Plus Unassayed - IA310X, IA314X, IA311X, IA312X, IA313X IA310MX Multichem IA Plus IA319X Multichem ID-COVID19Neg CVN100N Multichem AMH Unassayed AM500X/AM500MX Multichem IA Speciality Unassayed BP300X, BP301X, BP302X, BP303X, BP300MX Multichem ID-COVID19 G CVG200B Multichem ID-COVID19Neg CVN200N Multichem S Plus Unassayed CH100/101/102/103CRP, CH/110/111/112/113/CRP5 CH110MCRP5, CH100MCRP Multichem S Plus Unassayed Architect 05P79-10/11/12 Multichem NB Unassayed NB800X Multichem IA Plus (IA300A, 05P76-10, IA310A, IA311A, IA312A, IA313A) Multichem IA Plus (08P86-10) Multichem A1c HB000A, HB001A, HB002A, HB000M Multichem A1c 04V0610 Multichem U, 05P80-10 Multichem U UC201A.10 UC202A.10 Multichem IA Plus IA310A, IA311A, IA312A, IA313A, 05P76-10, 08P86-10, IA321A, IA322A, IA323A Multichem WBT WB000A, 05P77-10, 04S16-10 Multichem P 09339884190 Multichem AEC 10631627190, 10631643190, 10631651190 Multichem U 09339876190, 09339868190 Multichem S Plus CH100PLA, CH101PLA, CH102PLA, CH103PLA, CH110PLA5, CH111PLA5, CH112PLA5, CH113PLA Multichem AE Assayed Bi Level AE600A, AE601A, AE602A Multichem AE AE621A, AE622A, AE623A Multichem NB 06S7880 Multichem IA SET A 10631732190, 10631759190, 10631767190 Multichem IA Speciality 06S7831, 06S7832, 06S7833 Multichem S Plus 09339817190, 09339795190, 09339809190 Multichem IA Plus 09339841190, 09339850190, 09339825190 Multichem S Plus 05P78-10, 05P78-11, 05P78-12 Multichem P Assayed Alinity 08P90-10 Multichem S Plus Assayed Alinity 08P88-10/11/12 Multichem MS TDMs 09922571190, 09922580190 Multichem CSF Assayed CF100A, CF101A, CF102A Multichem P SP41PA, 05P81-10 Multichem A1c HB000A, HB001A, HB002A, HB000M, 04V06-10 Multichem MS VitD 09922555190, 09922563190 Multichem MS Steroids 09922512190, 09922547190 Multichem hsTn Assayed HS301A/MA Multichem LPS 06V83-10 Multichem CSF plus 10631686190, 10631716190 Multichem D-Dimer Assayed DM900A, DM900MA, DM901A, DM902A Multichem CSF 06S7801, 06S7802 Multichem D-Dimer 06S7891, 06S7892 Multichem hsTn Assayed 04W26-10 Multichem AE 06S7861, 06S7862, 06S7863 Multichem AE Trilevel Assayed AE610A, AE611A, AE612A, AE613A Multichem S Assayed CH101/102/103A & CH101/102/103A5 Multichem MS Free TDMs  10162066190, 10162074190 Multichem MS ISDs 09922598190, 09922601190 Multichem IA Speciality Assayed BP300A/BP301A/BP302A/BP303A Multichem NB Assayed NB800A Multichem U UC201A.10, UC202A.10, 05P80-10 Multichem IA Assayed IA300A, IA301A, IA302A, IA303A Multichem AMH Assayed AM500A/AM500MA, AM501A, AM502A, AM503A Multichem U Assayed Alinity 08P89-10 Multichem IA Plus 05P76-10 Multichem IA Plus, IA310A, IA311A, IA312A, IA313A, Multichem S Plus 05P78-10/11/12 Multichem WBT WB000A Multichem WBT, 04S16-10 Multichem ID-HIV p24 SR1111U Multichem ID-HIV p24 09915494190 Multichem ID-HIV p24 Mini Kit SR1111MU

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device