TECHNO-PATH MANUFACTURING LTD.

FDA Device Registration & Listing · Ballina Tipperary, IE · Registration 3008156187

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008156187
FEI Number
3008156187
Entity Name
TECHNO-PATH MANUFACTURING LTD.
City/State/Country
Ballina Tipperary, IE
Establishment Address
Fort Henry Business Park, Ballina Tipperary V94 FF1P, IE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Techno-path Manufacturing Ltd. (Owner Number: 10030933)
Owner / Operator Contact Address
Fort Henry Business Park, Ballina, IE-TA V94FF1P, IE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K132751
PMA Number
N/A

All Registered 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 CH100PLA, CH101PLA, CH102PLA, CH103PLA, CH110PLA5, CH111PLA5, CH112PLA5, CH113PLA Multichem S Plus 05P78-10/11/12

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-11-04
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2009-12-02
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2017-04-03
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-10-27
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-11-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2022-08-26
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-11-04
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-11-04

Official Correspondent

No official correspondent registered.

US Agent Details

Wais Osmani Business: LGC Clinical Diagnostics, INC. Email: wais.osmani@lgcgroup.com Phone: (774) 5735689

Related Public Records

Same Entity

Techno-path Manufacturing Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008156187. Last updated year: 2026. Please use registration number 3008156187 when referencing this establishment in official correspondence.
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